Report: Ex-FDA head Gottlieb to join conservative think tank
Departing FDA Commissioner Dr. Scott Gottlieb is returning to the conservative think tank American Enterprise Institute to focus on solutions to drug pricing issues, according to a report from The Hill.
Gottlieb will serve as a resident fellow at the Washington-based group, spending six days a month at its facilities in Washington D.C., according to the report.
“My colleagues and I am thrilled that [Gottlieb] is coming home to AEI. It will be wonderful to have him back at the lunch table. And we will benefit so much from AEI being his intellectual home. I’m excited for the work he will be doing,” AEI resident...
Source: Mass Device - April 4, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Food & Drug Administration (FDA) Source Type: news
Enlitic raises $15m in Series B
Artificial intelligence-enhanced medical diagnostics developer Enlitic said today that it closed a $15 million Series B round.
Enlitic is designing a platform that uses AI to develop algorithms to identify and analyze suspicious findings in medical images. The company’s first product is designed to interpret chest x-rays to triage normal from abnormal scans, and to detect and characterize more than 40 abnormalities.
The round was led by Marubeni and joined by Capital Health as well as several top Australian investors, the San Francisco-based company said. Enlitic added that it has been working with Marubeni since 201...
Source: Mass Device - April 4, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Imaging Enlitic Source Type: news
Orthofix Medical touts data from artificial disc study
Orthofix Medical’s M6-C artificial cervical disc (Image from Orthofix)
A study of patients implanted with Orthofix Medical’s (NSDQ:OFIX) M6-C artificial cervical disc showed a significant improvement in neck and arm pain, function and quality of life scores, the company said today.
Patients in the investigational device exemption (IDE) study also used less pain and opioid medication when compared with anterior cervical discectomy and fusion (ACDF) patients, and 92% reported they were satisfied with the surgery, the Lewisville, Texas-based business said in a prepared statement.
At 24 months, patients in the ACDF...
Source: Mass Device - April 4, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Clinical Trials Featured Food & Drug Administration (FDA) Implants News Well Orthopedics internationalsocietyfortheadvancementofspinesurgery (ISASS) Orthofix Source Type: news
Endologix closes $52m offering, debt refinancing deal
Endologix (NSDQ:ELGX) has closed a $52.2 million offering and debt exchange agreements with certain holders of its senior convertible notes for approximately $73.4 million, according to an SEC filing.
In its offering deal, announced earlier this week, the Irvine, Calif.-based company said it floated approximately 7.9 million new shares of its common stock at a price of $6.61 per share, receiving gross proceeds of approximately $52.2 million.
Endologix said that it expects to collect approximately $49 million after payment of fees and expenses and that the money will be used to support working capital and general corporat...
Source: Mass Device - April 4, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Wall Street Beat Endologix Source Type: news
Catapult, Smithwise slated to merge
Medical device development firms Catapult Product Development and Smithwise have agreed to merge.
Founded in 2012, Catapult is a full-service medical device development firm, specializing in console-based diagnostic and therapeutic systems, minimally-invasive surgical and diagnostic tools, and an array of portable and handheld medical equipment. The Waltham, Mass.-based company works extensively with startups to enable their core technologies, and with established device manufacturers and academic centers as they accelerate device development projects toward commercialization.
Get the full story on our sister site, Med...
Source: Mass Device - April 4, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Business/Financial News Mergers & Acquisitions News Well Research & Development catapultproductdevelopment smithwise Source Type: news
Tioga Medical raises $15m to support transcath mitral, tricuspid valve tech
Newly formed Shifamed portfolio company Tioga Medical said today that it closed a $15 million Series A preferred stock financing round to support its transcatheter mitral and tricuspid valve replacement technology.
The Campbell, Calif.-based company said that it is developing novel transcatheter valve replacement technology intended to be simpler and less invasive than current mitral and tricuspid valve replacement approaches.
Tioga Medical will initially focus on technology for mitral valve replacement, stating that there is a “significant clinical need for less invasive, transcatheter approaches for mitral valve r...
Source: Mass Device - April 4, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiac Implants Cardiovascular Catheters Replacement Heart Valves tiogamedical Source Type: news
Pulmatrix prices $14m offering
Pulmatrix (NSDQ:PULM) yesterday priced an upcoming offering looking to raise approximately $14.4 million.
The Lexington, Mass.-based company said that it plans to float approximately 10.7 million units at a price of $1.35 per unit. Each unit in the offering is comprised of one share of common stock and one warrant to purchase a single share of common stock.
Read the whole story on our sister site, Drug Delivery Business News
The post Pulmatrix prices $14m offering appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - April 4, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Wall Street Beat Pulmatrix Inc. Source Type: news
Loop Medical lands $3.2M grant for blood collection device
Loop Medical said today that it has received a $3.2 million grant from the Bill & Melinda Gates Foundation to support pre-production and clinical trials required for the global registration of its blood collection device. The foundation had previously given the company a $400,000 grant.
Based at the Swiss Institute of Technology (EPFL) in Lausanne, Switzerland, Loop Medical designed the device to be painless, easy-to-use and able to collect samples that are large enough for common high-throughput blood analyzers. The device was also designed to improve safety, particularly in countries with low medical resources.
In th...
Source: Mass Device - April 4, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Blood Management Business/Financial News Featured Funding Roundup Laboratory Instruments/Laboratory Supplies News Well Research & Development Bill & Melinda Gates Foundation cerbahealthcare loopmedical swedishinstituteoftechnolo Source Type: news
UPDATE: Silk Road Medical prices $120m IPO
Updated to include comment from CEO Erica Rogers
Silk Road Medical late yesterday priced its initial public offering, looking to raise approximately $120 million.
The Sunnyvale, Calif.-based company said it plans to float 6 million shares of its common stock at a price of $20 per share. The offering also includes a 30-day underwriters option to purchase an additional 900,000 shares of common stock.
Silk Road Medical produces the Enroute transcarotid neuroprotection and stent system, which is intended for use during the transcarotid artery revascularization procedure, or TCAR.
“The Enroute system is part of the devic...
Source: Mass Device - April 4, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Featured Vascular Wall Street Beat Silk Road Medical Inc. Source Type: news
TherOx wins FDA approval for SuperSaturated Oxygen therapy
TherOx said today that it won pre-market approval from the FDA for its SuperSaturated Oxygen Therapy system for acute myocardial infarction.
Irvine, Calif.-based TherOx touted the PMA as the first heart attack treatment approved to reduce infarct size since the federal safety watchdog OK’d percutaneous coronary interventions.
Indicated for patients suffering from left anterior descending ST-elevation myocardial infarction – the most deadly form of heart attack, known colloquially as the “widowmaker” – within six hours of onset and after stenting, SSO2 therapy delivers hyperbaric levels of oxygen direc...
Source: Mass Device - April 4, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Featured Regulatory/Compliance Wall Street Beat TherOx Inc Source Type: news
Avanos Medical wins FDA nod for ON-Q Bolus pump
Avanos Medical (NYSE: AVNS), which rebranded from Halyard Health last June, said today that it won FDA 510(k) clearance for its ON-Q* with Bolus pump drug infusion device.
The Alpharetta, Ga.-based company said that the new ON-Q* with Bolus system features improvements to improve ease of use and reduce postoperative opioid use for pain management.
Read the whole story on our sister site, Drug Delivery Business News (Source: Mass Device)
Source: Mass Device - April 3, 2019 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Drug Pumps Food & Drug Administration (FDA) Pain Management Regulatory/Compliance Avanos Medical (formerly Halyard Health) Source Type: news
Natus Medical deals Medix division to employees
Natus Medical (NSDQ:BABY) said yesterday that it inked a deal to sell its subsidiary Medix Medical Devices in an employee-led buyout.
In the sale, Pleasanton, Calif.-based Natus Medical said it is offloading the Medix line of products including incubators and warmers.
Natus said that Medix will continue to distribute the Medix products as well as the previously distributed line of Natus products and other third party products in Argentina and Venezuela. The separated Medix will also provide customer service, sales, customer support and warranty and repair services for the products.
“This divestiture is an important ...
Source: Mass Device - April 3, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Mergers & Acquisitions Natus Medical Inc. Source Type: news
J & J and its surgical orthopedic robot: What you need to know
Johnson & Johnson (NYSE:JNJ) isn’t known for tooting its horn prematurely. The public won’t hear much about a new J&J device until the company’s good and ready.
So it should come as no surprise that J&J’s DePuy Synthes business has kept relatively mum about the robotically assisted knee surgery device it’s been developing. J&J entered the competitive surgical orthopedic robot world when DePuy Synthes bought Paris-based Orthotaxy and its orthopedic-surgery robot prototype in 2018.
DePuy Synthes gave attendees at the recent American Academy of Orthopedic Surgeons conference a peek at the latest prot...
Source: Mass Device - April 3, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Business/Financial News Featured Health Information Technology Orthopedics Robotics Surgical depuysynthes johnson&johnson orthotaxy Robotic Surgery Source Type: news
Report: Researchers create CT, MRI image-altering malware to expose vulnerabilities
A group of researchers have created a malware program designed to exploit vulnerabilities in computed tomography and magnetic resonance imaging equipment to add realistic, malignant-seeming growths to scans in a bid to draw attention to vulnerabilities in medical equipment networks, according to a Washington Post report.
Researchers Yisroel Mirsky, Yuval Elovici and two others at the University Cyber Security Research Center in Israel created the malware program for use in a blinded study involving real CT scans, according to the report.
A total of 70 images were altered by the malware and were able to fool three skilled r...
Source: Mass Device - April 3, 2019 Category: Medical Devices Authors: Fink Densford Tags: Featured Imaging Software / IT Source Type: news
FDA nixes Evoke Pharma ’s gastro nasal spray
The FDA has rejected Evoke Pharma’s (NSDQ:EVOK) application for a metoclopramide nasal spray for diabetic women with gastroparesis.
The Solana Beach, Calif. company’s stock price tumbled 40% on the news yesterday that the agency had found dosing inconsistencies in the pivotal pharmacokinetic study for the spray, Gimoti. In an earlier multi-disciplinary letter to the company, the FDA had cited concerns with quality control, dosing, and a lack of information to support sex-based differences in efficacy.
Get the full story on our sister site, Drug Delivery Business. (Source: Mass Device)
Source: Mass Device - April 3, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Business/Financial News Drug-Device Combinations Food & Drug Administration (FDA) News Well Pharma Pharmaceuticals Regulatory/Compliance Women's Health evokepharma Source Type: news
