FDA EUAs go to 1st blood purifiers for COVID-19 patients, new N95 sterilizers

Terumo and CytoSorbents are behind blood purification devices designed to reduce inflammatory proteins in COVID-19 patients admitted to the ICU with confirmed or imminent respiratory failure.

By Susan Kelly • April 13, 2020

Court sides with Nevro over Boston Scientific in pain device patent dispute

A judge in the U.S. Court of Appeals for the Federal Circuit found a lower court erred in invalidating four Nevro patents covering high-frequency spinal cord stimulation.

By Nick Paul Taylor • April 10, 2020

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Top 5 stories from MedTech Dive

From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.

By MedTech Dive staff

Abbott lands CE mark for tricuspid sibling of MitraClip

The milestone for its structural heart business follows a a CE mark it received for a trancatheter mitral valve replacement device, as it still awaits U.S. approval of a transcatheter aortic valve replacement device.

By Nick Paul Taylor • April 10, 2020

Medtechs adapt to new sales reality amid halt on elective surgeries, hospitals' financial stress

Device manufacturers can't control how long COVID-19 shuts down the procedures and traditional sales models they depend on. But their flexibility during the down period can make or break the restart, industry advisers say.

By Maria Rachal • April 9, 2020

EU permits remote notified body audits during pandemic

The guidance came the day after the Council of the EU responded to the European Commission's proposal for a one-year delay to the Medical Device Regulation, which Parliament is set to vote on next week.

By Nick Paul Taylor • April 9, 2020

GM, Philips land $1.1B in HHS ventilator contracts, Medtronic boosts production

Much of industry has been prodded to ramp up production of the often large, complex and pricey breathing devices barely mentioned in company financials before the pandemic but now are critical for the sickest COVID-19 patients.

By Nick Paul Taylor • April 9, 2020

Coronavirus chaos ripe for hackers to exploit medical device vulnerabilities

Interpol warned that cybercriminals are using ransomware to target healthcare organizations already overwhelmed by COVID-19, and noted a significant increase in detected health system attacks since the start of the pandemic.

By Greg Slabodkin • April 8, 2020

Harvard, INSEAD authors pitch systemic regulatory approach to AI/ML devices

A new paper in Nature's digital medicine journal argues that real-world performance of specific SaMD products using artificial intelligence will vary considerably by hospital and other factors.  

By Nick Paul Taylor • April 8, 2020

Embolism risk prompts FDA to treat Boston Scientific recall as Class I event

The agency is aware of nine injuries resulting from detached tips of angiographic catheters, used to deliver contrast agents to blood vessels.

By Nick Paul Taylor • April 8, 2020

Study questions TAVR access disparities under new CMS coverage policy

The number of hospitals offering the less invasive aortic valve disease treatment could double under Medicare's revised coverage, but limited access in rural and safety net hospitals appears likely to persist, according to research.

By Susan Kelly • April 7, 2020

FDA OKs changes to oxygenation devices to treat coronavirus patients

A surge in patients with the sudden acute respiratory syndrome led to easing of allowed uses for cardiopulmonary bypass devices and ECMO machines. Medtronic and Getinge are among makers of the impacted devices.

By Nick Paul Taylor • April 7, 2020

FDA allows for infusion pump modifications to prevent shortages

In a bid to "reduce supply chain interruptions and manufacturing bottlenecks" during the pandemic, the agency will permit some changes to the pumps and accessories without the added step of a new 510(k) submission.

By Susan Kelly • April 6, 2020

Industry cheers COVID-19 executive order to boost ventilator supply chain

While AdvaMed has pushed back on using the Defense Production Act, the move is meant to help domestic manufacturers by removing hurdles to accessing parts and materials needed to ramp up production of ventilators.

By Greg Slabodkin • April 3, 2020

Medtechs navigate new normal as FDA shifts priorities to coronavirus

Companies are working to get diagnostics, respiratory devices and PPE to market amid rapidly evolving guidance from FDA. The agency's coronavirus-era operations may also impact work for device makers in other parts of the sector.

By Maria Rachal • April 3, 2020

OrthoPediatrics buys FDA-approved scoliosis tech, challenging Zimmer for market

OrthoPediatrics scooped up ApiFix's minimally invasive deformity correction system, an alternative to spinal fusion procedures and Zimmer Biomet's vertebral body tethering technology.

By Maria Rachal • April 2, 2020

NuVasive suspends UK sales of Magec rod amid safety concerns

The move comes after regulators called for quarantining affected devices and X-rays for patients within three months to check for end cap separation, although the COVID-19 crisis could delay such actions.

By Nick Paul Taylor • April 2, 2020

Vulnerability in medication dispensing system flagged again by DHS cyber team

An alert Tuesday from the Department of Homeland Security is the third issued in relation to BD's Pyxis products in as many years.

By Nick Paul Taylor • April 1, 2020

Remote patient monitoring, ventilator payment among CMS flexibility as COVID-19 rages on

As many patients have required ventilators, Medicare will now cover respiratory devices and equipment for any medical reason a doctor determines instead of only under specific conditions. 

By Shannon Muchmore • March 31, 2020

Joint Commission backs clinicians' right to bring own PPE to work amid shortages

After nurses filed more than 125 complaints with OSHA, the accrediting body for many hospitals issued a statement supporting staff that bring their own personal protective equipment in light of insufficient supply.

By Hailey Mensik • March 31, 2020

FDA flags Class I recall of Medtronic brain stent, citing fracture reports

The agency has received at least 50 reports, including of 10 injuries and one death, tied to an issue with the delivery system that places the aneurysm-treating device in the artery. 

By Susan Kelly • March 31, 2020

Stenting matches bypass surgery in 10-year study of left main patients

The similar rates of mortality and major cardiac or cerebrovascular adverse events may be positive for drug-eluting stent makers such as Abbott and Boston Scientific.

By Nick Paul Taylor • March 31, 2020

High-risk devices with expedited reviews more likely to be recalled, research suggests

As FDA's Breakthrough Devices Program rises in popularity, a JAMA Internal Medicine analysis found almost two-thirds of Class III devices approved with priority review status between 2005 and 2015 were recalled.

By Nick Paul Taylor • March 31, 2020

AdvaMed wary of Trump's use of DPA to boost ventilator production

The medtech industry contends the Defense Production Act could strain the supply chain, but the administration says it's "working to sign contracts immediately" with GE, Medtronic, ResMed and other major manufacturers.

By Greg Slabodkin • March 30, 2020

Low-risk TAVR: Edwards results taper in 2nd year, Medtronic targets bicuspid market

The companies again looked to expand use of the procedure a year after presenting pivotal data at the American College of Cardiology meeting on the low-risk population, but results were less emphatic.

By Nick Paul Taylor • March 30, 2020

Medtronic's renal denervation system shows it can lower blood pressure

Results presented at the American College of Cardiology's virtual meeting come after a big setback in 2014 when the device failed to show effectiveness. 

By Susan Kelly • March 30, 2020