Putting Fat Cells to Use in Orthopedics
Arthroscopic knee surgery for degenerative knee disease is a common orthopedic procedure, reportedly performed more than two million times a year globally. And these are just the statistics for knee procedures. The shoulder, hip, wrist, elbow, and ankle joints are all also candidates for arthroscopic surgeries. A few studies have cast doubt about whether such surgeries are necessary. It is true that most of the time, patients report lessening of pain after the procedures. But could this be just a placebo effect? In the case of osteoarthritis in the knee, there is no evidence that arthros...
Source: MDDI - August 8, 2018 Category: Medical Devices Authors: Susan Shepard Tags: Orthopedics Source Type: news

Arthroscopic subacromial decompression doesn ’t best placebo for shoulder impingement
Arthroscopic subacromial decompression (ASD) was shown to provide no benefit over diagnostic arthroscopy at 24 months in patients with shoulder impingement, according to a study published in The BMJ.  (Source: Orthogate - Latest News)
Source: Orthogate - Latest News - August 5, 2018 Category: Orthopaedics Tags: Featured Editors Choice News Source Type: news

In-office diagnostic arthroscopy may be safe and effective
In-office needle-based diagnostic imaging appears to be statistically equivalent to surgical diagnostic arthroscopy in patients with knee pain, according to an article published online in Arthroscopy.  (Source: Orthogate - Latest News)
Source: Orthogate - Latest News - August 5, 2018 Category: Orthopaedics Tags: Featured Editors Choice News Source Type: news

Acromioplasty No Better Than Sham Surgery for Shoulder Impingement Pain Acromioplasty No Better Than Sham Surgery for Shoulder Impingement Pain
Subacromial decompression is no better than diagnostic arthroscopy for treating shoulder impingement, according to the FIMACT study.Reuters Health Information (Source: Medscape Orthopaedics Headlines)
Source: Medscape Orthopaedics Headlines - July 31, 2018 Category: Orthopaedics Tags: Orthopaedics News Source Type: news

Lumendi wins CE Mark, launches DiLumen EIP in EU
Lumendi said today it launched its DiLumen endolumenal interventional platform endoscope sleeve after winning CE Mark approval in the European Union for the device. The Buckinghamshire, U.K.-based company said its DiLumen EIP is a non-sterile, single-use sleeve designed to fit over standard endoscopes to stabilize the devices in the large intestine. Lumendi touted that the device has already been used in more than 400 procedures, and has been the subject of three clinical studies, the results of which are slated to be published later this year. “Receiving approval to apply the CE mark in Europe is critical to Lu...
Source: Mass Device - July 17, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Endoscopic / Arthroscopic Regulatory/Compliance Lumendi Source Type: news

7 medtech stories we missed this week: July 13, 2018
[Image from unsplash.com]From Angiodroid receiving CE Mark approval to Masimo launching its vital signs app, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Angiodroid wins CE Mark for Angiopulse IABP Angiodroid announced in a July 11 press release that it has received CE Mark approval for its AngioPulse intra-aortic balloon pump device. The AngioPulse uses a new system for intra-aortic balloon pumps based on pressure regulation. It is designed for weaning solutions and is suitable for all types of patients needing intra-aortic balloon pump therapy. 2. Visura Technol...
Source: Mass Device - July 13, 2018 Category: Medical Devices Authors: Danielle Kirsh Tags: 510(k) Diagnostics Food & Drug Administration (FDA) Imaging Patient Monitoring Regulatory/Compliance Surgical Ultrasound angiodroid Healcerio Lipogems Masimo MedTech Oculocare ReDress Visura Technologies Source Type: news

EndoGastric Solutions adds $31m
EndoGastric Solutions, which last week reported raising more than $25 million, said today that the total raise was $30.5 million. Redmond, Wash.-based EndoGastric Solutions said the round was led by existing backers Advanced Technology Ventures, Canaan Partners, Canepa Healthcare, Chicago Growth Partners, CRG, Radius Ventures, Sightline Partners and “several new healthcare investors excited about EGS’ commercial advances.” In a regulatory filing last week the company said it raised $25.4 million from 28 investors as part of a $35.5 million offering. Today EGS said it plans to use the i...
Source: Mass Device - July 10, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Endoscopic / Arthroscopic Funding Roundup Wall Street Beat endogastricsolutions Source Type: news

FDA Clears The Way: Lipogems' Receives FDA Clearance For Microfragmented Adipose Tissue System Utilizing Body's Own Fat To Support Tissue Repair In Orthopaedic And Arthroscopic Surgeries
NORCROSS, Ga., July 5, 2018 -- (Healthcare Sales & Marketing Network) -- Lipogems, a leader in medical technologies for orthopaedic physicians, announced U.S. Food and Drug Administration (FDA) clearance of the company's Lipogems Microfragmented Adipose T... Regenerative Medicine, Orthopaedic, FDA Lipogems, Microfragmented Adipose Tissue, Transplant (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - July 6, 2018 Category: Pharmaceuticals Source Type: news

Arthroscopy Guided Fixation of Posterior Malleolar Fractures Arthroscopy Guided Fixation of Posterior Malleolar Fractures
Find out how ankle injuries with posterior malleolar fractures were successfully treated utilizing this surgical approach.Current Orthopaedic Practice (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - July 6, 2018 Category: Consumer Health News Tags: Orthopaedics Journal Article Source Type: news

Nerve Block Approaches for Major Arthroscopic Shoulder Surgery Nerve Block Approaches for Major Arthroscopic Shoulder Surgery
This study examined alternatives to interscalene nerve block for arthroscopic shoulder surgery, which frequently causes hemidiaphragmatic paralysis.Anesthesiology (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - July 5, 2018 Category: Consumer Health News Tags: Anesthesiology Journal Article Source Type: news

Pulmonx wins FDA approval for Zephyr endobronchial valve
The FDA today granted pre-market approval under its breakthrough devices designation to the Zephyr endobronchial valve made by Pulmonx for treating severe emphysema. Emphysema, a chronic obstructive pulmonary disease, causes irreversible damage to the lung’s alveoli, trapping air during exhalation that in turn can cause the diseased tissue to grow larger and pressure healthy lung tissue. The Zephyr device is designed to decrease the volume of the chest to improve function in the heart, respiratory muscles and healthy lung tissue. Inserted via bronchoscopy, the pencil-eraser-sized valves prevent air from ent...
Source: Mass Device - June 29, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Endoscopic / Arthroscopic Food & Drug Administration (FDA) Regulatory/Compliance Respiratory Pulmonx Source Type: news

Apollo Endosurgery wins expanded FDA nod for OverStitch Sx system
Apollo Endosurgery said today it won special FDA 510(k) clearance for its OverStitch Sx endoscopic suturing system, an accessory for its already cleared OverStitch Sx system intended to simplify attachment of the device to compatible endoscopes. The Austin, Texas-based company said that the special clearance is the last regulatory nod it needed before it could introduce the system into the US market. The newly cleared accessory makes the system, which was previously limited in compatibility to a select number of dual-channel endoscopes, compatible with a wider range of endoscopes, Apollo said in a press release. Earli...
Source: Mass Device - June 29, 2018 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Endoscopic / Arthroscopic Food & Drug Administration (FDA) Regulatory/Compliance Surgical Apollo Endosurgery Source Type: news

7 medtech stories we missed this week: June 22, 2018
[Image from unsplash.com]From Accuray’s India approval to Masimo and PositiveID launching a Bluetooth-enabled thermometer, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. India approves Accuray’s Radixact X9 radiation therapy device Accuray announced in a June 21 press release that it has received an Atomic Energy Regulatory Board Type Approval in India for its Radixact X9 System. The approval allows the company to sell the TomoTherapy platform while allowing hospitals throughout India to import the system. The Radixact and TomoTherapy Systems are radiation th...
Source: Mass Device - June 22, 2018 Category: Medical Devices Authors: Danielle Kirsh Tags: 510(k) Cardiovascular Diagnostics Endoscopic / Arthroscopic Food & Drug Administration (FDA) Hospital Care Imaging Patient Monitoring Regulatory/Compliance Ultrasound Accuray Inc. Arcuro Medical BTG Masimo MedTech NuSight P Source Type: news

Johnson & Johnson launches new self-shortening Dynacord suture
[Image courtesy of Johnson & Johnson]Johnson & Johnson through its DePuy Synthes franchise has announced the U.S. launch of its Dynacord suture for soft tissue repair in areas such as the rotator cuff in the shoulder. The Dynacord suture, available on Healix Advance anchors, is part of the DePuy Synthes Mitek Sports Medicine portfolio. J&J launched Dynacord today at the San Diego Shoulder Institute’s 35th Annual Course. About a fifth of arthroscopic rotator cuff surgeries fail because of a loss of suture tension, which causes gaps to form in the tissue or between the tissue and bone, according t...
Source: Mass Device - June 20, 2018 Category: Medical Devices Authors: Chris Newmarker Tags: Business/Financial News News Well Orthopedics Surgical depuysynthes johnsonandjohnson Source Type: news

Apollo Endosurgery prices $21m offering
Apollo Endosurgery today priced a stock offering worth nearly $21 million for its line of bariatric and gastrointestinal devices. Austin, Texas-based Apollo said it plans to float roughly 3.75 million shares at $5.50 apiece, for gross proceeds of $20.6 million. The offering also includes a 45-day option for underwriter Craig-Hallum Capital of another 562,055 shares, which would add $3.1 million if exercised in full, the company said. In March, the FDA approved Apollo’s move to terminate a post-approval study of its Lap-Band weight loss device, based on availability of long-term safety and effectiveness data on t...
Source: Mass Device - June 20, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Endoscopic / Arthroscopic Funding Roundup Wall Street Beat Weight loss Apollo Endosurgery Bariatrics Source Type: news

Bronchoscopes still dirty after cleaning, study says
Photo by Michaela33 courtesy of Flikr A new study has found that currently acceptable methods of reprocessing reusable bronchoscopes left most devices contaminated and damaged. “The results are worrisome as patients undergoing bronchoscopy are commonly at high risk for infection due to transplant status, critical illness, or immune-suppression due to malignancy or chronic disease,” said the study, funded by 3M and supported by sterilization product maker Healthmark Industries. It was presented last week at the Association for Professionals in Infection Control’s annual conference APIC 2018, will be p...
Source: Mass Device - June 19, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Diagnostics Endoscopic / Arthroscopic Regulatory/Compliance Sterilization / Calibration 3m Healthmark superbugs Source Type: news

Researchers Assert Arthroscopic Partial Meniscectomy No Better Than Placebo Surgery
No abstract available (Source: Lippincott's Bone and Joint Newsletter)
Source: Lippincott's Bone and Joint Newsletter - June 15, 2018 Category: Orthopaedics Tags: CME Article Source Type: news

Can You Smell a Bidding War Brewing Over Boston Scientific?
Monday's headlines that Stryker may be making a play for Boston Scientific prompted industry analysts to play the "what if" game, dissecting potential benefits of such a marriage, how a deal of that size might impact the broader medical device industry, and the potential of other bidders to emerge. Just to be clear though, we still do not know at this point if Stryker really has approached Boston Scientific about a potential takeover, or if Boston Scientific is even receptive to the idea. Both companies declined to comment on the speculation Monday, citing their respective company policies. Canaccord Genuity's Ja...
Source: MDDI - June 13, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

Medical News Today: What is knee arthroscopy?
Knee arthroscopy is a surgical procedure. A surgeon inserts a tool called an arthroscope through a small incision. Using this scope and the camera attached, they can confirm diagnoses and often correct any issues affecting the joint. In this article, learn how to prepare and what to expect from knee arthroscopy. (Source: Health News from Medical News Today)
Source: Health News from Medical News Today - June 11, 2018 Category: Consumer Health News Tags: Surgery Source Type: news

7 medtech stories we missed this week: June 8, 2018
[Image from unsplash.com]From Royal Philips receiving FDA clearance to NeuroPace launching its epilepsy treatment device, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. FDA clears Philips’s Ingenia Elition 3.0T MR scanner Royal Philips announced in a June 5 press release that it has received FDA 510(k) clearance for its Ingenia Elition 3.0T MR solution and its two clinical applications Philips Compressed Sense and 3D APT. The products help clinicians perform exams up to 50% faster while increasing diagnostic confidence and improving patient experience. 2. Pent...
Source: Mass Device - June 8, 2018 Category: Medical Devices Authors: Danielle Kirsh Tags: 510(k) Diagnostics Endoscopic / Arthroscopic Food & Drug Administration (FDA) Hospital Care Imaging Implants Neurological Neuromodulation/Neurostimulation Patient Monitoring Regulatory/Compliance branchpointtechnologies Cook Medica Source Type: news

Arthroscopic repair of bony Bankart lesions in collision athletes - Shah N, Nadiri MN, Torrance E, Funk L.
BACKGROUND: The present study aimed to report the outcomes of acute and subacute arthroscopic bony Bankart repairs in collision athletes. METHODS: We reviewed 22 consecutive rugby players with traumatic anterior glenohumeral instability who underwe... (Source: SafetyLit)
Source: SafetyLit - May 30, 2018 Category: International Medicine & Public Health Tags: Economics of Injury and Safety, PTSD, Injury Outcomes Source Type: news

Lumendi wins FDA nod for DiLumen IS endoscopic scissors
Lumendi said today it won FDA 510(k) clearance for its DiLumen IS endolumenal interventional scissors, now indicated for cutting, dissecting and cauterizing tissue within the digestive tract during endoscopic procedures. The Westport, Conn.-based company touted the sterile, single-use disposable, monopolar electrosurgical device as the fourth it’s developed, and said that it and its recently cleared DiLumen CT are intended to help improve access and therapy in the colon and reduce the need for surgical interventions. The recently cleared C2  is a second-gen Endolumenal interventional platform designed to en...
Source: Mass Device - May 29, 2018 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Endoscopic / Arthroscopic Food & Drug Administration (FDA) Regulatory/Compliance Lumendi Source Type: news

Return-to-play and performance outcomes of professional athletes in North America after hip arthroscopy from 1999 to 2016 - Schallmo MS, Fitzpatrick TH, Yancey HB, Marquez-Lara A, Luo TD, Stubbs AJ.
BACKGROUND: The effect of hip arthroscopy on athletic performance compared with preinjury levels for professional athletes in different sports remains unknown. In addition, while return rates have been reported for professional baseball, football, and hock... (Source: SafetyLit)
Source: SafetyLit - May 21, 2018 Category: International Medicine & Public Health Tags: Economics of Injury and Safety, PTSD, Injury Outcomes Source Type: news

Auris Health, Ethicon ’ s NeuWave ink robot-assisted bronchoscope ablation dev deal
Auris Health, previously known as Auris Surgical Robotics, said today it inked a cooperative development and commercialization deal with Johnson & Johnson (NYSE:JNJ) division Ethicon’s NeuWave Medical subsidiary looking to develop systems for the robotically-assisted bronchoscopic ablation of lung lesions. Through the agreement, both companies will help develop an integrated system for robotic control, navigation and application of bronchoscope-delivered microwave ablation. The bronchoscope in development will be equipped with a small camera and accessory channel to allow tools to enter the lungs through the...
Source: Mass Device - May 16, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Endoscopic / Arthroscopic Respiratory Robotics aurishealth Ethicon johnsonandjohnson NeuWave Medical Inc. Source Type: news

Cook Medical wins FDA de novo nod for Hemospray
Cook Medical said yesterday it won FDA de novo clearance for its Hemospray endoscopic hemostat designed for treating bleeding in the gastrointestinal tract. The Hemospray product won indications from the FDA for treating non-variceal GI bleeds, the Bloomington, Ind.-based company said. Hemospray is a single-use device designed to deliver an aerosolized spray of a mineral blend to a bleeding site during endoscopic procedures, and can cover large areas including ulcers and tumors, according to an FDA release. “We are extremely pleased to receive this approval to market from FDA. We have worked diligently to bring ...
Source: Mass Device - May 8, 2018 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Endoscopic / Arthroscopic Food & Drug Administration (FDA) Regulatory/Compliance Cook Medical Source Type: news

Merit Medical gets in on NinePoint ’ s NvisionVLE OCT
NinePoint Medical said today that it inked a long-term deal with Merit Medical (NSDQ:MMSI) division Endotek to distribute its NvisionVLE optical coherence tomography device that includes strategic investment of an unspecified amount. “NinePoint Medical is committed to providing GI physicians an elegant and cost-effective OCT imaging solution to enable early and accurate diagnosis,” president & CEO Christopher von Jako said in prepared remarks. “Merit Medical Endotek is the ideal partner as they have the reputation, clinical experience, and complementary product portfolio to grow this busines...
Source: Mass Device - May 1, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Endoscopic / Arthroscopic Imaging Wall Street Beat Merit Medical Systems Inc. NinePoint Medical Inc. Source Type: news

Mayo Clinic opens new simulation skills lab to help staff learn, perfect clinical procedures
JACKSONVILLE, Fla.? A new procedural skills lab in the Mayo Clinic J. Wayne and Delores Barr Weaver Simulation Center at?Mayo Clinic in Florida will help staff learn and perfect various clinical procedures, including joint arthroscopy, spinal taps and kidney removal. In addition, participants in the lab will experiment, learn and refine new procedures on tissue [...] (Source: Mayo Clinic Florida News)
Source: Mayo Clinic Florida News - May 1, 2018 Category: Hospital Management Source Type: news

4 Trends Advancing Medtech
For the past 20 years, the Medical Design Excellence Awards have celebrated medical products that improve the quality and accessibility of healthcare. Our finalists this year carry on this tradition, while also keeping in step with today’s high-tech digital and consumer trends. With the help of our esteemed jurors, we have identified four key trends in this year’s group of finalists: risk reduction; faster, more-efficient healthcare delivery; the influence of the Internet of Things; and the consumerization of healthcare. We’ve been tracking a few of these trends in past awards programs, so they’re n...
Source: MDDI - April 27, 2018 Category: Medical Devices Authors: Daphne Allen Tags: MD & M East (New York) Design Source Type: news

Olympus inks endoscope image sharing deal with InterSystems
Olympus (TYO:7733) said yesterday it inked a deal with InterSystems to enhance Olympus’ Knowledge Exchange System with InterSystems HealthShare, which allows for the sharing of images taken during endoscopy procedures. Olympus said its KE system is a software platform for centralized reprocessing record and image management that connects to its Olympus devices. The company added the system eliminates the need to transfer images to external devices to share with patients and other providers, and that with the addition of HealthShare it will now be able share endoscopic images and to directly connect to electronic...
Source: Mass Device - April 20, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Endoscopic / Arthroscopic Imaging Software / IT intersystems Olympus Source Type: news

FDA warns against endoscope connectors
The FDA yesterday warned healthcare providers against using endoscope connectors in more than one patient without reprocessing, saying it hasn’t seen any acceptable tests demonstrating their safety. The federal safety watchdog said the connectors, which are used in more than one patient for gastrointestinal endoscopies over the course of 24 hours, connect the endoscope to a water supply. The agency recommended that providers use connectors that prevent patient fluid back-flow into the ‘scope, either as a one-time use or reprocessed after every patient. Erbe USA is the only company marketing a 24-hour multi-pati...
Source: Mass Device - April 19, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Endoscopic / Arthroscopic Food & Drug Administration (FDA) Erbe USA Source Type: news

Cantel Medical wins FDA nod for Advantage Plus endoscope reprocessor
Cantel Medical (NYSE:CMD) said today it won FDA 510(k) clearance for its Advantage Plus pass-thru automated endoscope reprocessor, making it the first AER available in the US, the company claims. The newly cleared device is designed for the high-level disinfection of commonly used endoscopes, including duodenoscopes, the Little Falls, N.J.-based company said. “We strive to deliver real life infection prevention solutions to address the complexities our customers face in setting up successful endoscopy departments. We believe the Advantage Plus pass-thru AER’s availability will transform our custo...
Source: Mass Device - April 18, 2018 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Endoscopic / Arthroscopic Food & Drug Administration (FDA) Regulatory/Compliance Cantel Medical Corp. Source Type: news

Facility Ownership and Arthroscopic Shoulder Surgery Use Facility Ownership and Arthroscopic Shoulder Surgery Use
A new study examines the utilization patterns of arthroscopic shoulder procedures performed at physician-owned facilities.Journal of the American Academy of Orthopaedic Surgeons (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - April 17, 2018 Category: Consumer Health News Tags: Orthopaedics Journal Article Source Type: news

Ceterix Ortho wins FDA nod for NovoStitch Pro meniscal repair system
Ceterix Orthopaedics said today it won FDA clearance for its next-gen NovoStitch Pro meniscal repair system. The Fremont, Calif.-based company said the newly cleared device is designed to allow surgeons to place stitches arthroscopically in tight joint compartments to treat meniscal tears that had previously been unrepairable. “This FDA clearance is another important milestone in our mission to reduce the number of meniscectomies and to save the meniscus. Ceterix continues to be the leader in meniscal repair by providing innovations that preserve tissue and sustain the natural biomechanics of the knee joint,&rdq...
Source: Mass Device - April 16, 2018 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Orthopedics Regulatory/Compliance Ceterix Orthopaedics Source Type: news

Newcastle Basic Knee Arthroscopy & ACL Course
Newcastle Basic Knee Arthroscopy & ACL Cadaveric Course 29th - 30th November 2018 This course is designed for surgeons aspiring to a career in orthopaedic surgery. This course will address arthroscopic techniques on the knee and ACL reconstruction and consist of hands-on minimal access workshop using fresh frozen cadaveric tissue. In addition it will cover clinical assessment of common knee conditions.     (Source: Orthogate - Latest News)
Source: Orthogate - Latest News - April 13, 2018 Category: Orthopaedics Tags: Featured Meetings Events Source Type: news

Reaction time and brake pedal depression following arthroscopic hip surgery: a prospective case-control study - Balazs GC, Donohue MA, Brelin AM, Brooks DI, McCabe MP, Anderson TD.
PURPOSE: The purpose of this study was to determine whether patients diagnosed with femoroacetabular impingement (FAI) syndrome have prolonged braking times compared with age- and gender-matched controls and how long after surgery braking times return to p... (Source: SafetyLit)
Source: SafetyLit - April 11, 2018 Category: International Medicine & Public Health Tags: Engineering, Physics, Structural Soundness and Failure Source Type: news

Funding Roundup: Swiss Advanced Vision seeks $21m for auto-focus IOL
Funding Roundup A clutch of medical device companies raised cash to fund their operations, includingAscentX Medical, Avenda Health, Global Kinetics, Nephros, OrthoSensor and Swiss Advanced Vision. Here’s a look at them, their technologies and how much they drummed up. Next>> The post Funding Roundup: Swiss Advanced Vision seeks $21m for auto-focus IOL appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - April 11, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Endoscopic / Arthroscopic Funding Roundup Optical/Ophthalmic Orthopedics Patient Monitoring Urology AscentX Medical Avenda Health Global Kinetics Corp. Nephros Orthosensor Inc. Swiss Advanced Vision Source Type: news

FDA OKs limited duodenoscope sterilization by Custom Ultrasonics AERs
The FDA today announced that Custom Ultrasonics completed validation testing of its System Plus automated endoscope reprocessors, and that the devices are cleared for the reprocessing of certain duodenoscopes. With the clearance, the Philadelphia-based company’s line of System 83 Plus AERs are cleared for washing and disinfecting the Olympus (TYO:7733) TJF-180V and Pentax ED-3490TK duodenoscopes, according to an FDA release. The new clearance comes after the company supplied validation testing data which showed that the System 83 plus products can “effectively achieve high-level disinfection...
Source: Mass Device - April 10, 2018 Category: Medical Devices Authors: Fink Densford Tags: Endoscopic / Arthroscopic Food & Drug Administration (FDA) Regulatory/Compliance Sterilization / Calibration Custom Ultrasonics Olympus Pentax Source Type: news

Apax Partners-backed Co acquires India ’ s Healthium MedTech
Apax Partners said today that Quinag Acquisition, which is backed by funds advised by Apax, inked a deal to acquire India’s Healthium MedTech Private Limited, formerly known as Sutures India, in a deal worth approximately $350 million. A controlling stake in the company was acquired from existing shareholders TPG Growth, CX Partners and its founding shareholders, according to a press release from Apax. “TPG Growth has invested in a significant number of healthcare provider businesses around the world, from urgent care clinics and travel nurse staffing in the United States to world-class cancer clinics and ...
Source: Mass Device - April 6, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Mergers & Acquisitions Apax Partners healthiummedtech Source Type: news

UPDATE: Moll ’ s Auris wins FDA nod for Monarch robotic endoscopy platform
Updated to include commentary from Auris chief strategy officer Josh DeFonzo. Auris Health, previously known as Auris Surgical Robotics and formed by Intuitive Surgical (NSDQ:ISRG) founder Dr. Frederic Moll, said today it won FDA clearance for its Monarch robotic endoscopy platform. The Redwood City, Calif.-based company said it’s Monarch robotic platform’s initial aim will be on treating lung cancer, with the FDA clearance indicating the device for use in diagnostic and therapeutic bronchoscopic procedures. Auris touted that the system enables more accurate diagnosis and treatment of small and hard-to-rea...
Source: Mass Device - March 23, 2018 Category: Medical Devices Authors: Fink Densford Tags: Endoscopic / Arthroscopic Food & Drug Administration (FDA) Regulatory/Compliance Respiratory Robotics aurishealth Source Type: news

Moll ’ s Auris wins FDA nod for Monarch robotic endoscopy platform
Auris Health, previously known as Auris Surgical Robotics and formed by Intuitive Surgical (NSDQ:ISRG) founder Dr. Frederic Moll, said today it won FDA clearance for its Monarch robotic endoscopy platform. The Redwood City, Calif.-based company said it’s Monarch robotic platform’s initial aim will be on treating lung cancer, with the FDA clearance indicating the device for use in diagnostic and therapeutic bronchoscopic procedures. Auris touted that the system enables more accurate diagnosis and treatment of small and hard-to-reach nodules in the periphery of the lung. “Technology has advanced signif...
Source: Mass Device - March 23, 2018 Category: Medical Devices Authors: Fink Densford Tags: Endoscopic / Arthroscopic Food & Drug Administration (FDA) Regulatory/Compliance Respiratory Robotics aurishealth Source Type: news

FDA issues warning letters to Olympus, Fujifilm, Pentax over duodenoscope issues
The FDA said today it issued warning letters to Olympus (TYO:7733), Fujifilm Holdings (TSE:4901), and Hoya‘s Pentax Medical over failures to comply with federal orders to conduct postmarket surveillance studies to assess the effectiveness of reprocessing duodenoscopes. The order, issued by the federal watchdog in 2015, required all three manufacturers to conduct postmarket surveillance studies to determine whether healthcare facilities were able to properly clean and disinfect duodenoscopes. Manufacturers were also required to conduct a study to sample and culture reprocessed duodenoscopes in clin...
Source: Mass Device - March 9, 2018 Category: Medical Devices Authors: Fink Densford Tags: Endoscopic / Arthroscopic Food & Drug Administration (FDA) Regulatory/Compliance Fujifilm Holdings Hoya Corp. Olympus Pentax Medical Source Type: news

13th Hanover Arthroscopy & Arthroplasty Course
2 days only shoulder 09 – 10 November 2018. Live surgeries, live clinical examination, live indication for surgery. Congress language German (simultaneous translation into English). (Source: Orthogate - Latest News)
Source: Orthogate - Latest News - March 6, 2018 Category: Orthopaedics Tags: Featured CME Courses Events Source Type: news

Boston Scientific picks up EMcision
Boston Scientific (NYSE:BSX) said today that built out its biliary offering with the acquisition of endoscope maker EMcision for an undisclosed amount. London- and Montreal-based EMcision makes the Habib EndoHPB probe, which is designed to coagulate tissue in the gastrointestinal tract in treating pancreaticobiliary cancers. Marlborough, Mass.-based Boston Scientific said the probe has 510(k) clearance from the FDA and CE Mark approval in the European Union. “As we continue to search for ways to treat pancreaticobiliary cancers, we also seek to improve the quality of life for patients living with a cancer diagno...
Source: Mass Device - March 5, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Endoscopic / Arthroscopic Mergers & Acquisitions Oncology Wall Street Beat Boston Scientific emcision Source Type: news

Motus GI wins CE Mark for Pure-Vu system
Motus GI said today it won CE Mark approval in the European Union for its flagship Pure-Vu system designed to clean poorly-prepped colons during colonoscopies. Approval was supported by positive results from a 47-patient European clinical study of the Pure-Vu system in cleaning poorly prepared colons, which showed an increase in the number of adequately cleansed patients from 19.1% at baseline to 100% after use. “I believe the Pure-Vu System has tremendous potential to provide physicians with an easy-to-use device that enables a quality exam for patients, especially those who experience difficulty with the prep,...
Source: Mass Device - March 1, 2018 Category: Medical Devices Authors: Fink Densford Tags: Endoscopic / Arthroscopic Regulatory/Compliance MOTUS GI Source Type: news

Three Rivers Medical wins CE Mark for Rio aneurysm embolization device
Three Rivers Medical said yesterday that it won CE Mark approval in the European Union back in October for its Rio embolization coil for treating brain aneurysms. Mountain View, Calif.-based Three Rivers said it also treated the first 10 patients with the Rio device, which is also CE Marked for peripheral embolizations. The company said it plans to go to market via distributor in territories that recognize the mark. “The use of embolization coils to treat intracranial aneurysms continues to be the global gold standard for therapeutic neurovascular interventions and is proven to be safe and effective for both rup...
Source: Mass Device - February 21, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Endoscopic / Arthroscopic Neurological Regulatory/Compliance Three Rivers Medical Source Type: news

Motus GI closes $18m IPO
Motus GI last week closed an initial public offering worth $18 million for its Pure-Vu system for intra-colonoscopy cleaning. Fort Lauderdale-based Motus said it plans to use the proceeds to commercialize Pure-Vu and for R&D, among other things. The company said it sold 3.5 million shares at $5 apiece, grossing $17.5 million, and also granted a 30-day over-allotment of 525,000 shares to its underwriters. Motus GI originally hoped to raise $28.8 million in the IPO when it announced it in early January. When the company set its terms for the offering, it had a midpoint of nearly $26 million. The stock...
Source: Mass Device - February 20, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Endoscopic / Arthroscopic Funding Roundup Initial Public Offering (IPO) Wall Street Beat MOTUS GI Source Type: news

Orthofix launches RCStim rotator cuff repair trial
Orthofix (NSDQ:OFIX) said today it launched a study looking to evaluate the use of pulsed electromagnetic field technology with the company’s RCStim device as adjunctive treatment to the surgical repair of rotator cuff tears. The 538-patient study, which has begun enrollment, will evaluate the safety and effectiveness of PEMF technology designed to promote bone growth and whether it can reduce the rate of repaired tendons being subsequently torn, as well as overall improvement in patient outcomes. “Arthroscopic repair of rotator cuff tears can improve pain and functional use of the shoulder but a continuin...
Source: Mass Device - February 13, 2018 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Orthopedics Orthofix Source Type: news

17 black innovators who made medtech better
From cardiology to endoscopy to blood transfusion, African Americans have played an important role as innovators in the history of medicine and medtech. To help mark African American History Month, here’s a look at some of their greatest achievements. Here are 17 black innovators who have made discoveries and invented devices to make medtech better. Next>> The post 17 black innovators who made medtech better appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - February 9, 2018 Category: Medical Devices Authors: Danielle Kirsh Tags: Blood Management Cardiac Assist Devices Cardiac Implants Cardiovascular Diagnostics Endoscopic / Arthroscopic Hospital Care Laboratory Instruments/Laboratory Supplies Oncology Pharmaceuticals Research & Development American Red Cross Source Type: news

Pentax Medical recalls ED-3490TK duodenoscopes
Hoya‘s Pentax Medical is recalling its ED-3490TK duodenoscopes looking to replace parts of the scopes to prevent leakage of patient fluids into the device, according to an FDA release. The company is looking to replace the forceps elevator mechanism, o-ring seal and distal end covering to prevent leakage of fluids into the closed elevator channel and under the distal cap, according to the FDA release. The federal watchdog said it cleared updated design and labeling for the duodenoscope, and that it is closely monitoring the association between so called ‘superbug’ outbreaks and the use of reproc...
Source: Mass Device - February 9, 2018 Category: Medical Devices Authors: Fink Densford Tags: Endoscopic / Arthroscopic Food & Drug Administration (FDA) Recalls Pentax Medical Source Type: news

Motus GI sets terms for $26m IPO
Motus GI yesterday set the range for its pending initial public offering, which at the midpoint would fetch nearly $26 million. Last month the Israeli company, which makes the Pure-Vu intra-colonoscopy cleaning system, registered the IPO at roughly $28.8 million. Motus GI won FDA clearance for the device in September 2016. Yesterday Motus said it plans to float 4.25 million shares at $5 to $7 apiece, for a range of about $21.3 million to nearly $29.8 million. The company said it plans to list on the NASDAQ exchange under the symbol “MOTS,” noting that Piper Jaffray and Oppenheimer are acting as joint ...
Source: Mass Device - February 1, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Endoscopic / Arthroscopic Funding Roundup Wall Street Beat MOTUS GI Source Type: news