FDA: Page 63
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FDA touts lessons from Pre-Cert, though next steps murky
Apple, Fitbit and Johnson & Johnson are among nine companies in the pilot launched in 2019 to fast-track digital health products to market. But there's no end in sight as tests continue.
By Greg Slabodkin • Sept. 15, 2020 -
FDA
Another BD Alaris recall pegged Class I event by FDA
It's the latest in a flurry of notifications about the infusion pump line of products, which have been the subject of 18 of the high-risk recall notices since March.
By Nick Paul Taylor • Sept. 15, 2020 -
Explore the Trendlineâž”
Permission granted by Boston Scientific
TrendlineNew medical devices are reshaping the medtech industry
From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.
By MedTech Dive staff -
Jacob Bell/MedTech Dive
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agency's discussion paper on a proposed regulatory framework, critical pieces are still needed for the development of draft guidance, agency digital health chief Bakul Patel said.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
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 -
Jacob Bell/MedTech Dive
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 -
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 -
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 -
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 -
Roche COVID-19, flu combo test gets FDA emergency authorization
It is the fourth EUA for a diagnostic that detects and differentiates the viruses. However, the company claims to be the first commercial test that runs on fully automated high-throughput systems using a single sample.
By Greg Slabodkin • 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 -
Brian Tucker/MedTech Dive
Final inpatient payment rule confirms price transparency push
The American Hospital Association quickly criticized the CMS decision to move forward with collecting data on hospital median payer-specific negotiated charges to guide relative Medicare payment rates.
By Hailey Mensik • Updated 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 -
Courtesy of Quest Diagnostics
Florida cuts ties with Quest after delayed reporting of 75K COVID-19 test results
Gov. Ron DeSantis ordered all Florida agencies to sever testing relationships with the lab giant, which apologized for the delay in getting data to state health authorities in the timely manner required by law.
By Susan Kelly • 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 -
Alex Wong via Getty Images
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 -
HHS backs COVID-19 antigen testing for nursing homes, preempting regional restrictions
Although some state and local authorities are concerned about the accuracy of such rapid diagnostics, sold by Abbott, BD and others, the move comes amid rising calls for their use to test large numbers of people.
By Nick Paul Taylor • 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 -
Jacob Bell/MedTech Dive
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 -
"White House Press Briefing". Retrieved from The White House.
Abbott gets $760M contract from HHS to deliver 150M antigen tests
The deal comes just one day after the company's antigen test received FDA emergency use authorization. BD, Quidel and LumiraDx previously got the agency's nod for their diagnostics.
By Greg Slabodkin • Aug. 28, 2020 -
Foundation Medicine wins FDA OK for pan-tumor test as liquid biopsy market heats up
The approval for the FoundationOne Liquid CDx follows the agency's nod earlier this month for Guardant Health's next-generation sequencing diagnostic.
By Greg Slabodkin • Aug. 27, 2020
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