FDA AI-machine learning strategy remains work in progress

Nearly 18 months since the agency's discussion paper on a proposed regulatory framework, critical pieces are still needed for the development of draft guidance, agency digital health chief Bakul Patel said. 

By Greg Slabodkin • Sept. 14, 2020

FDA advisers support down-classing bone growth stimulators, in face of industry and lawmaker pushback

But the orthopaedic devices panelists said there should be rigorous clinical evidence standards for the class of products currently sold by Orthofix, Zimmer Biomet, Bioventus and DJO, which are yet to be defined.

By Maria Rachal • Sept. 11, 2020

Explore the Trendline➔

Medical device industry continues to turn to AI

While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.

By MedTech Dive staff

Thermo Fisher hikes growth forecast, expects COVID-19 sales to top $3B in late 2020

The company forecasts significantly higher growth this year than it's posted in the past, despite suffering a slow first quarter due to early disruption from the pandemic.

By Nick Paul Taylor • Sept. 11, 2020

FDA aims to harmonize adverse event reporting with eMDR updates, makes patient problem codes public

The agency finalized adding new elements and fields to its Electronic Medical Device Reporting system, and also clarified protocols for manufacturers with EUAs or following COVID-19 enforcement policies.

By Nick Paul Taylor • Sept. 10, 2020

The best TAVR device? Experts opine on when to use Boston Scientific, Edwards or Medtronic valve

A JAMA Cardiology review found design differences may give each transcatheter aortic valve replacement device small competitive advantages in certain circumstances.

By Nick Paul Taylor • Sept. 10, 2020

Medtronic tricuspid valve replacement device wins FDA breakthrough status

Although the medtech's Intrepid device is just starting an early feasibility study, it may ultimately go up against transcatheter tricuspid valve repair options from Abbott and Edwards.

By Maria Rachal • Sept. 9, 2020

Ultrasound ablation provided 'adequate' short-term control for prostate cancer patients, small study shows

Only 9% of men treated with products from SonaCare or EDAP TMS required surgery or radiation over the next two years, but larger studies are needed to better show how well HIFU works, a Journal of Urology publication concluded.

By Nick Paul Taylor • Sept. 9, 2020

Ortho device reclassifications, MDUFA reauthorization among FDA's fall meeting lineup

The agency's upcoming slate of virtual medtech meetings kicks off Tuesday with an orthopaedic devices panel that will consider a proposal to downclassify noninvasive bone growth stimulators.

By Susan Kelly • Sept. 8, 2020

Surgeries keep rising, buoying Wall Street's year-end medtech outlook

Jefferies reported a fourth consecutive week of growing hospital traffic, while Bank of America is "broadly bullish" on the medical devices sector as 2020 wraps up.

By Greg Slabodkin • Sept. 8, 2020

Edwards gets FDA approval for Sapien 3 in new patient population

The PMA expands the transcatheter valve for use in congenital heart defect patients who suffer problems following surgical repair, positioning the device to compete against a range of treatment options.

By Nick Paul Taylor • Sept. 8, 2020

Abbott resurrects resorbable scaffold tech for below-the-knee trial

The medtech previously stopped selling the technology amid evidence it increased the risk of major adverse cardiac events, but recent data has revealed a new BTK opportunity.

By Nick Paul Taylor • Sept. 4, 2020

FDA flags 428 spinal cord stimulator patient deaths, urges more tests before implant

The agency revealed the figures in a letter to healthcare providers urging simulations prior to permanently implanting the devices, sold by companies such as Abbott, Boston Scientific, Medtronic and Nevro.

By Nick Paul Taylor • Sept. 4, 2020

Watchdog gives high marks to CMS competitive bidding program

The Office of Inspector General probe found the agency followed procedures 97% of the time when awarding contracts for durable medical equipment, prosthetics, orthotics and supplies.

By Nick Paul Taylor • Sept. 3, 2020

Boston Scientific, Stryker win CMS new tech add-on pay, BD left out

When combining eligible devices with other recipients, including drug therapies, the agency estimates spending on the payments will total roughly $874 million, a 120% year-over-year increase. 

By Maria Rachal • Sept. 2, 2020

Stryker reaches agreement with Colfax for Wright Medical deal divestitures

The medtech disclosed Thursday the orthopaedics competitor's DJO Global subsidiary agreed to acquire its ankle and finger joint replacement businesses to shore up U.S. and U.K. antitrust concerns.

By Maria Rachal • Updated Oct. 16, 2020

HHS terminates Hamilton, Vyaire ventilator contracts

The Strategic National Stockpile now has an adequate supply of the devices, the agency said. The two companies will not deliver the additional 38,000 ventilators they'd planned by year's end.

By Greg Slabodkin • Sept. 2, 2020

UK outlines post-Brexit medical device regime starting January

Regulators unveiled a future U.K. Conformity Assessed (UKCA) mark, but will continue recognizing CE marks until mid-2023 and give companies four to 12 months to register their devices and in vitro diagnostics.

By Nick Paul Taylor • Sept. 2, 2020

Baxter wins FDA De Novo for more expansive dialyzer

The medtech is still working on convincing CMS to support add-on Medicare payments for the devices.

By Maria Rachal • Sept. 1, 2020

Medtronic artificial pancreas gets FDA nod for young kids

The medtech is introducing MiniMed 770G, a Bluetooth-enabled version of the first hybrid closed looped system to get agency approval, bridging the gap to a device launching in Europe this fall but delayed in the U.S.

By Nick Paul Taylor • Sept. 1, 2020

CMS pitches coverage of breakthrough devices in tandem with FDA authorization

The proposal follows years of AdvaMed lobbying for products awarded the special FDA designation to gain Medicare reimbursement upon clearance or approval.

By Maria Rachal , Susan Kelly • Aug. 31, 2020

FDA proposes adding patient voice in device evaluation

The draft guidance comes nearly two years after an advisory committee prioritized greater inclusion of the patient perspective in device design, development and assessment. Two more public meetings are planned.

By Susan Kelly • Aug. 31, 2020

Philips lowers 2020 outlook as HHS nixes ventilator contract

The medtech received a "partial termination" notice and will not deliver 30,700 remaining ventilators to the Strategic National Stockpile, a month after a House panel called for a probe into the roughly $647 million contract.    

By Greg Slabodkin • Aug. 31, 2020

EU MDR costing smaller medtechs 5% of their annual sales: survey

Almost 70% of 101 companies surveyed by a German software provider said they spend most of their time related to the new rules deciphering what the incoming EU Medical Device Regulation means.

By Nick Paul Taylor • Aug. 31, 2020

Stryker stretches Wright Medical share offer into Q4

As the medtech makes the fifth offer extension since the $4 billion acquisition was announced last November, the company is approaching the latest time it said the deal would close.

By Susan Kelly • Updated Sept. 29, 2020

Clinical trial links hospital use of Dexcom G6 to improved glucose control

Scripps Whittier Diabetes Institute researchers found the sensors safe and effective in the hospital setting, newly cleared by FDA amid the pandemic. Whether the benefits justify the additional cost is unclear.

By Nick Paul Taylor • Aug. 28, 2020