FDA wants to update mammography standards
The FDA today issued a proposed rule that would modernize mammography quality standards and require mammography facilities to provide more information to patients and healthcare providers.
The proposed rule would be the first update in 20 years, amending regulations issued under the Mammography Quality Standards Act of 1992, which authorizes FDA oversight over mammography facilities, including their accreditation, certification, annual inspections and enforcement of standards. The new proposal could help patients and providers make more informed decisions regarding care, and boost the FDA’s regulatory power over the ...
Source: Mass Device - March 27, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Featured Food & Drug Administration (FDA) Imaging Mammography News Well Oncology Regulatory/Compliance Women's Health nationalcancerinstitute Source Type: news
3m settles dental crown case for $33m
3M Cos. (NYSE:MMM) agreed to settle a proposed class-action lawsuit brought over alleged defects in its Lava Ultimate dental crown product.
The lawsuit, filed in May 2016 in the U.S. District Court for Minnesota by 39 dentists who used the Lava Ultimate crowns, alleged that they failed at rates that were “orders of magnitude higher than those seen in any other crown material.” More than 1 million Lava Ultimate crowns were sold before 3M pulled the crown indication from the market in June 2015, according to court documents.
“3M represented that its Lava Ultimate restorative product provided dentists and pa...
Source: Mass Device - March 27, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Dental Featured Legal News 3m Source Type: news
10 women in medtech manufacturing you should know
Women account for nearly one-third of employees in the manufacturing industry, where men have historically held the majority of jobs, according to the U.S. Census Bureau.
The situation includes manufacturers and other outsourcers serving the medical device space.
The lack of diversity is even more apparent farther up the corporate leadership ladder. According to a report from the Centers for American Progress, women hold 52% of professional jobs in the U.S., but only 14.6% of CEOs are women.
The Equal Employment Opportunity Commission also reports that only a fifth of executives, senior officers and managers in the U.S. h...
Source: Mass Device - March 27, 2019 Category: Medical Devices Authors: Danielle Kirsh Tags: Contract Manufacturing 3m criterion Eastman Chemical eldonjames integer promenadesoftware protolabs surfacesolutionlabs Women in Medtech Source Type: news
DarioHealth, Glytec ink joint marketing deal
DarioHealth (NSDQ:DRIO) said today it inked a joint marketing agreement with Glytec through which DarioHealth’s smart glucose meter will be able to transmit information to Glytec’s Glucommander Outpatient software.
Israel-based DarioHealth said that blood glucose data from its Dario Blood Glucose Monitoring System will now be imported into the Glucommander Outpatient for use in conjunction with other clinical data to create personalized insulin dose recommendations.
Read the whole story on our sister site, Drug Delivery Business News
The post DarioHealth, Glytec ink joint marketing deal appeared first on MassD...
Source: Mass Device - March 27, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Diabetes Featured DarioHealth Corp Glytec Source Type: news
CMS touts ‘ more flexibility ’ in new TAVR coverage requirements
The Centers for Medicare and Medicaid Services have proposed new policy that could expand the use of transcatheter aortic valve replacement procedures, touting that it may provide more flexibility for starting and maintaining TAVR programs.
The original National Coverage Determination for TAVR procedures was cleared in 2012, when the technology and associated procedure was still new. The new policy from CMS looks to update requirements based on new information about the safety and viability of the procedures.
The new proposal, released yesterday, would reduce the number of cardiac surgeons required to independently examine...
Source: Mass Device - March 27, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiac Implants Cardiovascular Replacement Heart Valves Centers for Medicare and Medicaid Services (CMS) Source Type: news
Sight Sciences launches Omni eye surgery study
Sight Sciences said today that it launched a clinical trial of its Omni eye surgery device in sequential, minimally invasive glaucoma procedures.
Menlo Park, Calif.-based Sight Sciences said the 130-patient Gemini study is designed to evaluate the use of Omni in consecutive MIGS procedures involving transluminal viscoelastic delivery and trabeculotomy at 12 months. The single-arm trial’s primary outcomes are change in mean unmedicated diurnal intraocular pressure and change in mean number of IOP-lowering drugs. Secondary outcomes include percent of eyes with a more than 20% reduction in unmedicated diurnal IOP and pe...
Source: Mass Device - March 27, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Clinical Trials Featured Optical/Ophthalmic Sight Sciences Source Type: news
CHF Solutions touts reduced cost, hospital stays in Aquadex Flex Flow ultrafiltation study
CHF Solutions (NSDQ:CHFS) today released results from a study of its ultrafiltration, such as with its Aquadex Flex Flow system, as compared to diuretic therapy for treating heart failure patients, touting a reduction in hospital duration and readmissions.
The Eden Prairie, Minn.-based company said that results from the study were published in the Journal of Medical Economics.
In the study, investigators examined clinical data from literature and hospital data from the Healthcare Cost and Utilization Project to follow decision analytic framework and explored treatment decisions, costs and outcomes for treating heart failu...
Source: Mass Device - March 26, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Clinical Trials CHF Solutions Inc. Source Type: news
Another medtech sterilization plant will close in 2019
A second medical device sterilization plant is slated to close this year, prompting the FDA and medtech manufacturers to scramble for replacements.
The FDA warned on March 1 about a potential medical device shortage due to the recent shutdown of a Sterigenics plant in Willowbrook, Ill. linked to emissions of the highly carcinogenic chemical compound ethylene oxide. The Willowbrook plant sterilized 594 types of devices, including sutures, clamps, knives, stents and needles. The FDA said it isn’t aware of any device shortages attributable to the Willowbrook facility closure but that existing supplies could be diminished...
Source: Mass Device - March 26, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Business/Financial News Featured Food & Drug Administration (FDA) News Well Outsourcing Sterilization / Calibration Centers for Disease Control & Prevention (CDC) Sterigenics International Inc. viant Source Type: news
ConvaTec taps Bitar as CEO | Personnel Moves – March 26, 2019
ConvaTec (LON:CTEC) said today it tapped Karim Bitar as its new CEO, set to take the position on September 30.
Prior to joining the U.K.-based medtech company, Bitar served as CEO of agricultural biotech company Genus, holding the corner office position for approximately eight years.
Before his time with Genus, Bitar spent 15 years in various roles with Eliy Lilly, serving as prez of Europe, Australia and Canada.
“I am delighted to announce Karim’s appointment as chief executive officer of ConvaTec. He is an experienced and highly regarded leader with an excellent track record of delivering impressive results and ...
Source: Mass Device - March 26, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Featured Baxter Cantel Medical Corp. ConvaTec Fresenius Lantheus micronsolutions Millstone Medical Outsourcing Monarch Medical Pavmed sonedo Source Type: news
Breath Therapeutics launches Ph3 trial for inhaled liposomal cyclosporine A therapy
Privately-held Breath Therapeutics said today that it kicked off a Phase III clinical program for its liposomal formulation of cyclosporine A for the treatment of bronchiolitis obliterans syndrome.
The company’s primary drug candidate, L-CsA-i, is an inhaled therapy delivered via Pari Pharma‘s investigational eFlow nebulizer.
Get the full story at our sister site, Drug Delivery Business News.
The post Breath Therapeutics launches Ph3 trial for inhaled liposomal cyclosporine A therapy appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - March 26, 2019 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Drug-Device Combinations Pharmaceuticals Respiratory breaththerapeutics paripharma Source Type: news
Hydrocision, Procept BioRobotics ink licensing deal
Hydrocision said today that it inked an exclusive worldwide licensing deal to allow Procept BioRobotics to use its pump cartridge technology for urological applications.
Through the agreement, Redwood Shores, Calif.-based Procept BioRobotics will gain the rights to use Boston-based Hydrocision’s pump cartridge technology in its AquaBeam robotic system designed to performed autonomous tissue removal for treating benign prostatic hyperplasia.
“This global agreement with Procept BioRobotics is another significant and strategic step to bring the value of our differentiated technology into new surgical applications ...
Source: Mass Device - March 26, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News HydroCision Inc. Procept BioRobotics Source Type: news
Boston Scientific prevails in employment case
Boston Scientific (NYSE:BSX) has won summary judgment in an employment discrimination lawsuit brought by a former regional manager.
Boston Scientific fired the former manager, Michael Simons, in 2015 for impaired job performance due to alcohol consumption, being intoxicated at work events and getting arrested for drunken driving during work hours and failing to disclose the arrest, according to the facts of the case.
After the company issued two written warnings to Simons about his behavior, Simons emailed his supervisor citing complaints by Simons’ staff about the supervisor’s behavior. A company investigatio...
Source: Mass Device - March 26, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Legal News News Well Boston Scientific Source Type: news
J & J ’ s DePuy Synthes goes after Orthofix, ex-reps in poaching lawsuit
Johnson & Johnson (NYSE:JNJ) unit DePuy Synthes last week sued Orthofix (NSDQ:OFIX) and a pair of former DePuy sales reps, alleging that its rival lured the reps and two other colleagues away so it could poach DePuy clients in Alabama and Texas.
According to the suit, filed in the U.S. District Court for Eastern Texas, DePuy hired Thomas Wells and Michael Sewell in 2012 as sales consultants for DePuy Synthes for the territory around Dothan, Ala. After the duo quit in March 2017 within hours of each other, the suit alleged, routine inventory checks at one of their clients revealed Orthofix devices and instruments that ...
Source: Mass Device - March 26, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Featured Legal News Orthopedics depuysynthes Orthofix Personnel Moves Source Type: news
Dune Medical launches first-in-man Smart Biopsy trial
Dune Medical Devices said today that it launched a first-in-man trial of its Smart Biopsy device, touting that the first patients in the trial have already been treated.
The first-in-man cases were performed by Dr. Noemi Weissenberg of Kfar Saba, Israel’s Meir Medical Center, the Alpharetta, Ga.-based company said.
Dune Medical’s Smart Biopsy system is a percutaneous soft tissue biopsy device that uses miniaturized sensors in the core needle to generate electrical parameters on sampled tissue in real-time. Those electrical signals are compared to histopahtologic findings to improve diagnosis and read-out.
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Source: Mass Device - March 26, 2019 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Diagnostics Dune Medical Devices Inc. Source Type: news
Silk Road Medical sets downsized range for IPO
Silk Road Medical yesterday set the range on its forthcoming initial public offering, which would fetch $75 million at the midpoint.
The Sunnyvale, Calif.-based company’s Enroute transcarotid stent and neuroprotection system is designed to treat carotid artery blockages before they cause a stroke. When it registered the IPO earlier this month, Silk Road said it could fetch as much as $86 million. But yesterday the company said it plans to float nearly 4.7 million shares at $15 to $17 apiece, for gross proceeds of $70.5 million to $79.9 million.
Silk Road has said it plans to use the cash to expand its sales force and ope...
Source: Mass Device - March 26, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Featured Funding Roundup Wall Street Beat Silk Road Medical Inc. Source Type: news
