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

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

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

Medtronic starts FY22 with electives boost, but delta hits in summer months

Executives said the variant hit in late July and continued into August, though predicted the surge would not be as bad as last year.

By Ricky Zipp • Updated Aug. 25, 2021

EU builds out MDR, IVDR guidance ahead of flurry of implementing acts

The European Commission has advice on notified bodies, quality management systems and COVID-19 tests, among other topics, as medtechs work to comply with the new and looming regulations.

By Nick Paul Taylor • Aug. 24, 2021

Robotic mastectomy's safety and effectiveness unproven, FDA warns

The agency doesn't call out specific firms. Intuitive Surgical is studying its da Vinci Xi system in prophylactic nipple-sparing mastectomy procedures, but tells MedTech Dive it has the required approval.

By Susan Kelly • Updated Aug. 23, 2021

Remote collaboration from the operating room: The 'new normal' for medtech

For too long, medical information sharing and collaboration has depended on in-person communication. The COVID-19 pandemic has caused us to rethink how we deliver healthcare.

By Jerry Carter, Avail Medsystems • Aug. 23, 2021

Post call: How a pandemic transformed healthcare for the future

From the frontlines of 2020 to the forefront of the future, what worked, what didn’t, and what must be prioritized today to thrive tomorrow. 

Aug. 23, 2021

J&J chief Alex Gorsky to step down early next year

Citing family health reasons, Gorsky will transition to the role of executive chairman and pass his torch to Joaquin Duato, currently vice chairman of J&J's executive committee.

By Jacob Bell • Aug. 20, 2021

Biden said to rule out Woodcock as permanent FDA chief

A published report indicated the agency's longtime drug reviewer is no longer in consideration for the role, leaving it unfilled seven months into President Joe Biden's term.

By Jonathan Gardner • Aug. 20, 2021

TAVR sites concentrated in urban areas linked to mortality risk, study finds

Mayo Clinic cardiologists used the findings to call for CMS to withhold reimbursement from sites that fail to meet its original selection or quality criteria.

By Nick Paul Taylor • Aug. 20, 2021

Abiomed leads latest FDA breakthrough designations for heart disease devices

The agency awarded the breakthrough privileges to Abiomed's Impella ECP, which the company contends is the world's smallest heart pump and could provide critical hemodynamic support to coronary artery disease patients.

By Nick Paul Taylor • Aug. 19, 2021

FDA warns of BlackBerry cyber vulnerability in medical devices

The operating system is often deployed in devices such as cardiac and patient monitors, drug infusion pumps, imaging and surgical robots, according to Nick Yuran, CEO of security consultancy Harbor Labs.

By Greg Slabodkin • Aug. 18, 2021

Zimmer's Rosa total hip system gets FDA nod, fueling robotics rivalry

The clearance allows the medtech to keep pace with Stryker's Mako line. However, delta variant surges could limit procedure volumes in the second half.

By Ricky Zipp • Aug. 18, 2021

Industry pitches FDA with 26% rise in user fee funding in MDUFA V negotiations

The offer tops $1.2 billion but represents a sharp slowdown in the rate of user fee hikes seen in earlier iterations of MDUFA. AdvaMed declined to comment.

By Nick Paul Taylor • Aug. 18, 2021

FDA seeks more power for medical device cybersecurity mandates

CDRH wants to require medtechs to have a Software Bill of Materials ready upfront as part of a premarket submission, as well as the capability to update and patch device security into a product's design.

By Greg Slabodkin • Aug. 17, 2021

Boston Scientific's vaginal mesh studies entrench FDA's view that risks outweigh benefits

After halting sales of the product in 2019, the regulator said the additional risks associated with transvaginal mesh repair mean it "continues to believe that these devices do not have a favorable benefit-risk profile."

By Nick Paul Taylor • Aug. 17, 2021