Medical Devices

AdvaMed urges Biden to prioritize medical supplies as industries suffer shipping constraints

CEO Scott Whitaker said transport challenges, including shipping container shortages and insufficient trucking capacity, have impeded the ability of medtechs to deliver products while also significantly driving up costs.

By Ricky Zipp • June 23, 2021

Pear secures $400M to scale up digital therapeutic business in SPAC deal

The developer of the first three FDA-authorized prescription digital therapeutics has ambitions to grow sales from a projected $4 million this year to $125 million in 2023.

By Nick Paul Taylor • June 23, 2021

Explore the Trendline➔

Trendline

How medtechs are navigating the sales environment after the pandemic

The impact of the pandemic on the industry was far from even, given the diversity of companies in the space — from those that make heart valves to artificial hips and knees to robotics to point of care testing.

By MedTech Dive staff

Deep Dive

Legacy medical devices, growing hacker threats create perfect storm of cybersecurity risks

Aging medtech and increasingly sophisticated criminals are leaving hospitals highly vulnerable to attacks.

By Greg Slabodkin • June 22, 2021

Philips recall could be $300M opportunity for ResMed: analysts

The Baird analysts warned it's a heavy lift, suggesting hitting a $100 million to $300 million range would require about 10% to 20% of the impacted Philips devices to transition to ResMed.

By Nick Paul Taylor • June 22, 2021

Medicare CGM eligibility widened in potential boon for Abbott, Dexcom

CMS opened up coverage for therapeutic continuous glucose monitors, eliminating a rule that patients must use a blood glucose monitor and require at least four self-monitoring blood glucose tests per day to have devices covered.

By Ricky Zipp • June 18, 2021

FDA seeks feedback on distinction between device remanufacturing and servicing

The long-awaited draft guidance is meant to clarify a blurry line between the two processes. The Medical Imaging and Technology Alliance contends remanufacturing is being done by unregulated third-party device servicers.

By Nick Paul Taylor • June 18, 2021

Roundup: Medtronic's HeartWare HVAD pump recalls and decision to exit

There's been a whirlwind of regulatory activity around Medtronic's HeartWare HVAD pump. Here's a compendium of MedTech Dive's coverage of FDA recalls and the company's decision to discontinue the system.

Hip, knee bundled pay program results similar as voluntary or mandatory: JAMA study

The results of a University of Pennsylvania analysis of more than a million Medicare claims for joint replacement surgery lend support to CMS' expected policy shift toward more mandatory bundled payment arrangements.

By Susan Kelly • June 16, 2021

FDA advisory panel to review TransMedics' liver preservation device

The Gastroenterology and Urology Devices Panel will meet virtually on July 14 to discuss the company's filing for premarket approval of the OCS Liver system, which is designed to keep donor organs viable for longer.

By Nick Paul Taylor • June 15, 2021

ResMed's stock climbs following Philips' sleep apnea, ventilator device recall

Wall Street analysts wrote the recall could drive patients and durable medical equipment providers to ResMed devices, though any benefits right now are "impossible to quantify."

By Ricky Zipp • UPDATED: June 16, 2021 at 10:50 a.m.

FDA rejects Verily filing for wrist-worn Parkinson's clinical trial device

The sister company of Google developed the feature to collect data on the motor function of Parkinson's patients in between visits to trial sites. However, the agency questioned the wearable's ability to have a meaningful effect. 

By Nick Paul Taylor • June 14, 2021

EC issues medtech guidance on implant cards required under MDR

The European Commission detailed information implant manufacturers need to provide under the new rules, while also publishing a document on the European Medical Device Nomenclature and how it relates to IMDRF terminology.

By Nick Paul Taylor • June 14, 2021

Medtronic's FDA approval sets up fight for recharge-free pain market

The medtech sees Vanta helping it gain share in a market it has struggled to penetrate in the past. Abbott Laboratories, Boston Scientific and specialist spinal cord stimulation rival Nevro are also competing.

By Nick Paul Taylor • June 11, 2021

FDA lays out device cybersecurity efforts as feds look to implement Biden executive order

The president signed an order last month seeking to bolster the nation's cyber posture amid growing threats from hackers. 

By Greg Slabodkin • June 09, 2021

Medtronic's HeartWare HVAD ending brings questions about $1B acquisition

Nearly five years after Medtronic's buy of HeartWare International, the medtech giant pulled the flagship product of the deal due to safety risks, ceding the market to rival Abbott.

By Ricky Zipp • June 08, 2021

Medtronic lands FDA approval for brain stimulation leads it expects to drive share gains

CEO Geoff Martha has boasted the nod for SenSight will help it close "a key competitive gap." The medtech competes with Abbott and Boston Scientific in the market. 

By Nick Paul Taylor • June 08, 2021

Cancer tech dominates FDA's latest batch of breakthrough devices

The agency's recent breakthrough designations feature a clutch of oncology devices and diagnostics from companies including Viome and Avenda Health.

By Nick Paul Taylor • June 07, 2021

Dexcom shares clinical data on G7 CGM ahead of next-gen showdown with Abbott

The results compare favorably to data on Abbott’s Libre 2, further setting the stage for the release of one of the most anticipated new products of 2021 in the diabetes tech market.

By Nick Paul Taylor • June 04, 2021

Medtronic pulls HeartWare HVAD pump from market amid recalls, patient deaths

The medtech said the move was influenced by growing evidence the system had higher mortality risks than comparable devices. FDA advised providers to use Abbott's HeartMate 3 as an alternative.

By Ricky Zipp • June 03, 2021

FDA warns device makers of falsified records at Italian ethylene oxide sterilization facilities

BD and Medtronic are among those that already recalled products processed by Steril Milano, accused by the agency of falsifying graphs and parameters of sterilization certificates for a variety of products dating back to 2016.

By Nick Paul Taylor • June 03, 2021

Abiomed buys preCARDIA to bag breakthrough heart failure device

William Blair analysts had hopes the buy could help Abiomed move past "two years of commercial disruptions" to drive long-term growth.

By Nick Paul Taylor • June 02, 2021

Amid pricing tumult, iRhythm CEO resigns after 4 months in office

After taking over on Jan. 12, Mike Coyle stepped down Tuesday. CFO Douglas Devine will assume the role amid a search for a permanent replacement. Shares were down by nearly 17% Wednesday morning.

By Ricky Zipp • June 02, 2021

FDA seeks 8% budget boost for CDRH to back resurgence of domestic device production

The Biden administration said its request for the Center for Devices and Radiological Health will help the U.S. reduce reliance on products from China and other countries and strengthen its ability to respond to emergencies.

By Nick Paul Taylor • June 01, 2021

Swiss medtech sounds alarm as MDR erects barriers to EU market

The Swiss Medical Technology Association said the change will cost the industry it represents the equivalent of $126 million to meet new administrative requirements.

By Nick Paul Taylor • May 28, 2021

Medtronic steps up robotics bet as its challenger to Intuitive starts clinical trial

The medtech giant seeks to double or triple sales in its 2023 fiscal year. However, analysts warned that near-term investments will pressure margins in the short term.

By Nick Paul Taylor • May 28, 2021