CMS moves to scrap MCIT rule due to clinical evidence concerns

AdvaMed said the repeal of the Medicare Coverage of Innovative Technology rule is the wrong decision for patients. Analysts wrote the breakthrough device pathway could be resurrected in Cures 2.0 legislation. 

By Nick Paul Taylor • Sept. 14, 2021

Medtechs are boosting DTC investment, but industry still years behind pharma

Companies are spending hundreds of millions of dollars every year on direct-to-consumer advertising as the industry focuses on marketing more to patients.

By Ricky Zipp • Sept. 14, 2021

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Medical device safety in spotlight after high profile recalls

From Philips’ massive recall of respiratory devices to ongoing health risks with breast implants, medical devices tied to patient harm have put a focus on product safety.

By MedTech Dive staff

NuVasive warns of delta hit in Q3 as hospitals once again limit electives

The company's update offers another early indicator that medtechs will likely be hit in the third quarter due to delta variant surges.

By Nick Paul Taylor • Sept. 14, 2021

MedTech Europe calls for urgent clarification of EU artificial intelligence proposal

The trade group worries "unnecessary overlaps" between the proposed AI Act and medical device regulations, such as MDR and IVDR, could affect access to products as well as lead to legal uncertainty.

By Nick Paul Taylor • Sept. 13, 2021

Jefferies lowers medtech outlooks as hospitals project delta pressure into Q4

The investment bank lowered its third quarter outlook for medical device companies with revenues heavily based on surgical volumes, including Boston Scientific, Medtronic and Stryker.

By Rebecca Pifer • Sept. 13, 2021

iRhythm announces new CEO, the second since December, amid tumultuous 2021

Quentin Blackford, who is leaving the position of chief operating officer for Dexcom, will officially take over the role on Oct. 4. iRhythm's stock price shot up by over 34% Monday morning following the announcement.

By Ricky Zipp • Sept. 13, 2021

FDA ends summer with fresh batch of breakthrough device designations

Novocure and CellMax Life are among the latest to get regulatory privileges for experimental devices used to treat and detect cancers.

By Nick Paul Taylor • Sept. 10, 2021

ResMed touts CPAP survival benefits for sleep apnea after HHS doubts therapy efficacy

The ResMed-funded analysis of a French database comes on the heels of a government review finding the evidence does not back a link between continuous positive airway pressure therapy and clinically important outcomes.

By Greg Slabodkin • Sept. 9, 2021

Spine devices, recalls and endovascular stents on FDA's fall meeting lineup

Other topics include Integra's bid for approval of a device used as soft tissue support in post-mastectomy breast reconstruction and a workshop on artificial intelligence and machine learning. 

By Nick Paul Taylor • Sept. 8, 2021

TransMedics wins FDA nod for donor heart preservation system

Approval for the device comes two months after an FDA advisory panel backed the company's liver preservation system and follows the go-ahead for its donor lung technology in 2019.

By Susan Kelly • Sept. 7, 2021

Bill Gates-backed Vicarious Surgical targets Intuitive, J&J, Medtronic in abdominal robotic surgery

The robotics startup, with investors including BD, wants to grow sales to $1 billion by 2027. CEO and co-founder Adam Sachs told MedTech Dive legacy robot platforms have fallen short in terms of cost and efficiency.    

By Greg Slabodkin • Sept. 7, 2021

ECRI CEO: FDA, industry must revisit COVID-19 medical device EUAs as shortages ebb

Marcus Schabacker spoke to MedTech Dive about patient safety, cyberattacks in healthcare and risks from the rise of at-home care.

By Ricky Zipp • Sept. 3, 2021

Pandemic spurs rise of other infections contracted at healthcare facilities

The largest increase at hospitals from 2019 to 2020 was seen in bloodstream infections associated with central line catheters, according to the CDC.

By Hailey Mensik • Sept. 2, 2021

Baxter's $10.5B Hillrom buy on track, deal to close by early 2022: CEO

Baxter CEO Joe Almeida said the standard U.S. antitrust waiting period expired with no second FTC information request. Other global regulatory hurdles remain and shareholders are set to vote on the deal on Dec. 2.

By Greg Slabodkin • Updated Oct. 28, 2021

Smoking pot before knee, hip replacements linked with more complications

With marijuana use rising quickly in U.S. adults aged 45 to 64 years, three studies presented at the American Academy of Orthopaedic Surgeons meeting sought to find out if consumption affects outcomes.

By Nick Paul Taylor • Sept. 2, 2021

Zimmer 'smart knee' gets FDA nod as ortho rivalry with Stryker heats up

The orthopaedics device maker, through a collaboration with Canary Medical, becomes the first company to bring an implantable smart device for total knee replacement to the U.S. market.

By Susan Kelly • Aug. 31, 2021

Baxter in late-stage talks to buy Hillrom for about $10B: WSJ

A Baird analyst said he talked himself into backing a union given Hillrom's connected care push. However, J.P. Morgan analysts argued Baxter has a "tall order" convincing investors it's a "more strategic vs. financial" acquisition.

By Greg Slabodkin • Aug. 30, 2021

Outpatient facilities targeted for cyberattacks nearly as often as hospitals, data shows

The number of breaches at healthcare organizations in the first half of this year was up significantly from the first half of last year, and higher than any six-month period since 2018, according to the Critical Insight report.

By Hailey Mensik • Aug. 30, 2021

COVID-19 seems to skew Abbott heart failure monitor study results

The clinical trial of the CardioMEMS implantable sensor in a wider patient population missed its primary goal, but the company is moving forward based on an analysis adjusted for the pandemic.

By Susan Kelly • Aug. 30, 2021

Abbott's Amulet trial results could lift LAA closure market: analysts

Wall Street analysts were not surprised by the results given the recent FDA approval for Amulet, but agreed that the data was strong enough to boost the left atrial appendage closure products from Abbott and Boston Scientific.

By Nick Paul Taylor • Updated Aug. 31, 2021

Boston Scientific's Watchman riskier for women, registry finds

The review of outcomes of nearly 50,000 patients found women are more likely to suffer major adverse events because of bleeding or pericardial effusion requiring drainage.

By Nick Paul Taylor • Aug. 30, 2021

Philips cleared by FDA to start repairing recalled sleep apnea devices

The company expects repair and replacement programs to be completed in the next 12 months. CEO Frans van Houten said in a Wednesday statement that Philips has increased service capacity and patient outreach.

By Nick Paul Taylor • Updated Sept. 1, 2021

Abbott predicted to quickly take share from Boston Scientific's Watchman: survey

The poll of 56 electrophysiologists by SVB Leerink analysts is somewhat more encouraging for Boston Scientific than an earlier survey, but still highlights the threat to the franchise as it loses its monopoly in the space.

By Nick Paul Taylor • Aug. 26, 2021

Medtechs made it out of Q2 with minimal impact from delta. That could change in Q3.

After procedure-dependent medtechs reported strong elective returns in the first half of 2021, the delta variant is now posing a risk to the industry's recovery as hospitals once again shut down procedures.

By Ricky Zipp • Aug. 26, 2021

Hospital volume recovery on shaky ground amid delta, Kaufman Hall reports

Outpatient revenue fell in July, suggesting patients might again be delaying non-urgent care. The survey comes as elective dependent medtechs navigate the latest wave of the variant sweeping much of the South.

By Hailey Mensik • Aug. 25, 2021