Essure Discontinuation Doesn & #039;t Mean the End to FDA Scrutiny
FDA wants the public to know it is taking steps to make sure the long-term safety profile of a controversial birth control device continues to be studied even after U.S. sales of the device are discontinued at the end of the year. While this seems like a good idea, in theory, patient advocates have concerns about the validity and feasibility of the required post-market study.
Bayer announced in July that it would stop selling the Essure device at the end of the year due to a decline in U.S. sales. FDA Commissioner Scott Gottlieb said at the time that the agency would still hold the compa...
Source: MDDI - December 20, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Regulatory and Compliance Source Type: news
National Bowel Cancer Audit: annual report 2018
This ninth annual report from the National Bowel Cancer Audit examines data on over 30,000 patients diagnosed with bowel cancer between 01 April 2016 and 31 March 2017. It describes some ongoing improvements such as mortality rates following both elective and emergency surgery falling over the past five years and increased numbers of operations being performed laparoscopically. (Source: Current Awareness Service for Health (CASH))
Source: Current Awareness Service for Health (CASH) - December 19, 2018 Category: Consumer Health News Source Type: news
Operating Rooms Get a Dose of Augmented Reality
Operating rooms are set to get a dose of augmented reality because of a new clearance from FDA. The agency recently signed off on an augmented surgical navigation system from Mariner Endosurgery.
The Ontario-based company’s LaparoGuard is an augmented surgical navigation system that enables surgeons to annotate areas of 3D safety zones during minimally invasive procedures, to aid surgeons in guiding their tools and informing their surgical approach. Similar to the heads-up display of a fighter jet, LaparoGuard allows surgeons to annotate areas of risk, and then see 3D renderings of surgeon-defined safety ...
Source: MDDI - December 15, 2018 Category: Medical Devices Authors: Omar Ford Tags: Regulatory and Compliance Imaging Source Type: news
ConMed to acquire Buffalo Filter for $365m
ConMed (NSDQ:CNMD) said today that it inked a deal to acquire surgical smoke evacuation tech developer Buffalo Filter for $365 million.
Buffalo Filter develops and produces surgical smoke evacuation technologies, including smoke evacuation pencils, smoke evacuators and laparoscopic solutions, ConMed said.
Utica, N.Y.-based ConMed said that it expects to finance the transaction through a combination of new convertible notes and an expanded and amended credit facility. ConMed expects the acquisition to close in the first quarter of next year.
“We are excited to join ConMed and continue our mission of improving safety ...
Source: Mass Device - December 13, 2018 Category: Medical Devices Authors: Fink Densford Tags: Featured Mergers & Acquisitions Surgical ConMed Corp. Source Type: news
Surgeon Experience and Medicare Expenditures for Colectomy Surgeon Experience and Medicare Expenditures for Colectomy
How do Medicare payments for laparoscopic and open colectomy compare? Might a surgeon ' s experience impact payment?Annals of Surgery (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - December 10, 2018 Category: Consumer Health News Tags: General Surgery Journal Article Source Type: news
Olympus wins FDA nod for Spiration bronchial valve
Olympus (TYO:7733) said yesterday that it won FDA approval for its Spiration Valve System intended to treat severe emphysema, which was designated as a breakthrough medical device.
The Spiration Valve is an umbrella shaped device intended to improve breathing by blocking airflow to diseased portions of the lung, the Tokyo-based company said. The device is placed during a bronchoscopic procedure to reduce lung volume in diseased lung sections and allow healthier tissue in the remaining portion of the lung to function better.
Approval of the device came based on the results from the Emprove clinical trial of the SVS, which...
Source: Mass Device - December 6, 2018 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Regulatory/Compliance Respiratory Olympus Source Type: news
Imaging dev Lightpoint Medical raises $6m
Medical imaging dev Lightpoint Medical said today it raised approximately $6.4 million (GBP £5 million) in a new financing round slated to support the commercialization of the company’s robotic laparoscopic probe and its LightPath imaging system.
Money in the round came from Cambridge Capital Group, Venture Founders, Coutts Investment Club, Envestors, Fund Twenty8, SyndicateRoom and Oxford Technology, the Chesham, U.K.-based company said. It added that it has also raised more than $3.8 million (GBP £3 million) from Horizon 2020 SME instrument and Innovate UK.
“We are very proud to have supported Lightpoint M...
Source: Mass Device - December 6, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Imaging lightpointmedical Source Type: news
TIGR(R)Matrix shows promising results when used for incisional hernia prevention in septic patients undergoing laparoscopy
UPPSALA, Sweden, Dec. 4, 2018 -- (Healthcare Sales & Marketing Network) -- Onlay mesh placement of the synthetic and fully resorbable TIGR®Matrix surgical mesh (Novus Scientific AB, Uppsala -- Sweden) for the prevention of incisional hernia in septic ... Devices, Surgery Novus Scientific, TIGR Matrix, surgical mesh, laparoscopy (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - December 4, 2018 Category: Pharmaceuticals Source Type: news
Upper GI X-rays Unhelpful After Sleeve Gastrectomy Upper GI X-rays Unhelpful After Sleeve Gastrectomy
Gastrografin upper gastrointestinal inspection is generally of little value in determining the integrity of staple lines following laparoscopic sleeve gastrectomy, according to a retrospective review.Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - November 13, 2018 Category: Consumer Health News Tags: General Surgery News Source Type: news
Medtronic backs infant-sized miniature pacer
Medtronic (NYSE:MDT) is collaborating with researchers at the Children’s National Health System to develop a miniature pacemaker intended for use with infants.
The prototype version of the device was presented at the American Heart Association’s 2018 Scientific Sessions by Dr. Rohan Kumthekar of the Sheikh Zayed Institute for Pediatric Surgical Innovation, part of the Children’s National Health System.
The newly developed miniature pacer is designed to be implanted through a 1 cm incision just below the ribcage, eliminating the need for open-chest surgery, according to a CNHS report.
The device is implan...
Source: Mass Device - November 13, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Research & Development Medtronic Source Type: news
TransEnterix posts Street-beating Q3
TransEnterix (NYSE:TRXC) today posted third quarter earnings that beat expectations on Wall Street.
The Research Triangle Park, N.C.-based company posted losses of $20.2 million, or 10¢ per share, on sales of $5.4 million for the three months ended September 30, seeing losses shrink 47.5% while sales grew nearly 3000% compared with the same period during the previous year
Adjusted to exclude one-time items, losses per share were 6¢, just ahead of the 7¢ loss-per-share consensus on Wall Street where analysts expected to see sales of $5.3 million, which TransEnterix topped.
“We are proud of the progress we made dur...
Source: Mass Device - November 8, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Featured MassDevice Earnings Roundup Wall Street Beat TransEnterix Source Type: news
Eximis Working on a New Surgical Platform
Eximis Surgical has secured $7.5 million in financing to help develop a surgical platform for the removal large specimens through small laparoscopic incisions. The financing was led by Questa Capital with participation from Venture Investors.
The Louisville, CO-based company said it will use the new capital to fund U.S. regulatory approval and the commercial launch of the Eximis Laparoscopic Specimen Removal System.
The firm said its platform uses specimen removal technique to have multiple, integrated containment bags for increased confidence and a novel cutting technology that eliminates the need for sharps during segmen...
Source: MDDI - November 8, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news
Surgical Robotics Market Due for a Shake Up?
For years, Intuitive has been recognized as the leader of the surgical robotics market. But there are more competitors on the horizon and the entry level for the surgical robotics’ market is far easier than it used to be.
Roger Smith, MD, the Chief Technology Officer for the Florida Hospital Nicholson Center, spoke with MD+DI about the state of the surgical robotics market and what could possibly lie ahead for the space.
“When you look at the volume of procedures that are conducted with devices that are considered robotic, probably 70% are conducted with da Vinci,†Smit...
Source: MDDI - November 5, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news
Saving my life – Mel ’ s story
Hi, I am a 55yr old woman who had been through peri-menopause and not had a period for 18mths. Then in the beginning of July 18 I noticed my breasts felt larger and really very sensitive. In August I had a period which I thought strange so went to GP.
I was told not to worry but as there was a slight chance this could mean cancer I would be seen within 2wks at hospital. I tried not to worry and got my appt with the gynaecologist. He did a hysteroscopy and found a polyp which he said looked benign but needed to be sent for tests.
I later received a phone call from a gynaecologist nurse telling me that I had pre-cancerous ce...
Source: The Hysterectomy Association - November 5, 2018 Category: OBGYN Authors: Linda Parkinson-Hardman Tags: Health hysterectomy stories rectocele Source Type: news
