Supreme Court redefines limits on patent attacks by inventors in Hologic decision

The High Court upheld the doctrine that stops inventors challenging their own patents but placed limits on its use.

By Nick Paul Taylor • June 30, 2021

FDA wants to require timely updates, patches for legacy devices: cyber chief

Kevin Fu, acting director of device cybersecurity, spelled out the agency's plans to protect aging devices from hackers. There's no current statutory requirement compelling manufacturers to address the problem.

By Greg Slabodkin • June 30, 2021

Explore the Trendline➔

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

Roundup: Trial results, looming product releases fuel diabetes tech competition

In the first half of the year, the space is meeting Wall Street's high expectations for 2021. Here's a roundup of MedTech Dive's coverage of the market, including from this week's American Diabetes Association meeting.

June 30, 2021

Robotic abdominal surgery has no advantage over open, laparoscopic surgeries: meta-analysis

The review found of 39 studies reporting surgical complications, just 10% showed fewer complications with robot-assisted surgery. The analysis was published in the Annals of Internal Medicine.

By Greg Slabodkin • June 29, 2021

Medtronic smart insulin pen improved time in target blood glucose levels: study

The medtech giant's trial results come as competition in the space is intensifying. Eli Lilly and Bigfoot Biomedical, partnered with Abbott, are also prioritizing the technology.

By Ricky Zipp • June 29, 2021

FDA nod in sight, Insulet's Omnipod 5 boosts time in range in diabetes subset

The trial results show improved health outcomes in a crucial patient population for the company: individuals requiring multiple daily injections of insulin.

By Susan Kelly • June 28, 2021

Virtual selling expected to be the new normal of medtech sales in 2022

Due to the challenges of COVID-19 restrictions, medtech companies are beginning to replace siloed platforms that rely on in-person visits, disconnected systems and outdated marketing tech. 

June 28, 2021

Nevro's painful diabetic neuropathy data marred by disappointing Q2 forecast

CEO Keith Grossman said he's "frankly disappointed" at the pace of the recovery, suggesting the company may miss its sales target. Shares were down nearly 6% Monday morning.

By Nick Paul Taylor • June 28, 2021

EU clarifies Eudamed rules for legacy and custom-made devices

The Medical Device Coordination Group has provided information on products placed on the market under frameworks other than MDR and IVDR, which the advisers said should be registered in the database.

By Nick Paul Taylor • June 25, 2021

More than 1/3 of health organizations hit by ransomware last year, report finds

Of those attacked, 65% said the criminals were successful in encrypting their data, according to the report from cybersecurity company Sophos.

By Rebecca Pifer • June 24, 2021

Medicare lacks cyber oversight of hospitals' networked medical devices: OIG

Without proper cybersecurity controls, these devices can be compromised with the potential for patient harm, according to the HHS watchdog. OIG wants CMS to do more to address hospital vulnerabilities.

By Nick Paul Taylor • June 24, 2021

Boston Scientific spends $295M to snap up rest of cardiac ablation maker Farapulse

The deal adds to the medtech's electrophysiology portfolio in an increasingly competitive space that includes Medtronic and Johnson & Johnson.

By Ricky Zipp • June 24, 2021

Contentious device breakthrough payment rule codified in Cures 2.0 proposal

The measure would sidestep CMS' delay of the MCIT pathway, which grants Medicare coverage to FDA-approved breakthrough devices.

By Nick Paul Taylor • June 24, 2021

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

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 HVAD recall problems continue following patient injuries, deaths

One year after Medtronic pulled the heart pump off the market, there have been two Class I recalls following reports of patient injuries and deaths. Here is a collection of MedTech Dive's coverage of the HVAD saga.

Updated June 27, 2022

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

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