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

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

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

FDA outlines role for 3D printing in coronavirus response, with some caution

Additive manufacturing has emerged as a tool to help bolster availability of critical devices like ventilators and testing supplies, but the agency said 3D-printed personal protective equipment may not be as effective.

By Nick Paul Taylor • March 27, 2020

A better way to manage medical device inventory

By bringing the latest technology into the warehouse and out in the field, manufacturers and suppliers can reduce operational costs and stay competitive in a value-based environment.

March 27, 2020

FDA OKs anesthesia gas machines as ventilators amid coronavirus shortage fears

GE Healthcare, which has more than 100,000 of its anesthesia devices worldwide, noted differences but acknowledged the "need to weigh the relative risks and benefits to support patients in these unprecedented times."

By Greg Slabodkin • March 26, 2020

Medtech industry asks for FEMA's help allocating ventilators to frontlines

AdvaMed said a lead federal agency should be designated to manage distribution of the breathing machines as manufacturers rapidly scale up production in response to the COVID-19 crisis.

By Susan Kelly • March 25, 2020

How health systems are responding as COVID-19 squeezes the medical supply chain

Procurement of supplies will become more difficult if cases surge and federal stockpiles don't trickle down to the state level quickly enough.

By Deborah Abrams Kaplan • March 25, 2020

EU regulators propose 1-year MDR delay

The European Commission formally proposed Friday the Medical Device Regulation start date be moved to May 26, 2021. It needs the quick backing of the European Parliament and Council.

By Maria Rachal • Updated April 3, 2020

FDA still trying to fine-tune Pre-Cert as pilot enters 2020

The Pre-Cert​ pilot, which includes Apple, J&J and Fitbit, is moving forward with the agency "working through the nine companies, trying to figure out how they actually do business," FDA's Bakul Patel told MedTech Dive.

By Greg Slabodkin • March 25, 2020