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What’s next for Abbott’s cardiovascular business?

Abbott (NYSE: ABT) + boosted its vascular device offerings even more with its acquisition of Cardiovascular Systems this year.

Wondering what comes next? Abbott Vascular President Julie Tyler will explain at our DeviceTalks West event, Oct. 18–19 in Santa Clara. (Register here.)

Even as COVID-19 test sales continue to decline and hammer overall revenue, Abbott officials are betting on a productive, innovative pipeline to build momentum — especially in its medical device business. In a keynote interview on the morning of Oct. 18, Tyler will discuss the company’s product platform, innovation process, and what’s to come after the acquisition of Cardiovascular Systems.

How can the merger with Cardiovascular Systems enable Abbott to better help people with vascular diseases?

Find out more at DeviceTalks West.

Orthofix launches OsteoCove bioactive synthetic graft

[Image courtesy of Orthofix]Orthofix today announced it received FDA 510(k) clearance for its OsteoCove bioactive synthetic graft.

The graft is available in both a putty and strip configuration and Orthofix designed it to provide superior bone-forming capabilities with handling characteristics for a wide range of spine and orthopedic procedural applications.

“Using the same disciplined R&D approach we have historically taken with our internally processed demineralized bone matrix solutions, we created a product that challenges the performance expectations of typical synthetic bone graft substitutes,” said Orthofix Chief Scientific Officer Frank Vizesi. “OsteoCove is another prime example of leveraging our strengths in product development in combination with our vertically integrated manufacturing expertise.”

OsteoCove is made of biphasic ceramic granule that is comprised of β-tricalcium phosphate (ß-TCP) and hydroxyapatite (HA) combined with type-I bovi…

Medtronic Evolut FX TAVI wins CE mark approval

The Evolut FX system [Image courtesy of Medtronic]Medtronic (NYSE: MDT) + this week announced it received CE mark approval for the Evolut FX transcatheter aortic valve implantation system.

The Evolut FX is the latest generation TAVI of the company’s CoreValve/Evolut TAVI platform. Medtronic designed it to enhance ease-of-use and provide greater precision and control throughout the procedure for clinicians treating patients with severe aortic stenosis.

Evolut FX uses the same supra-annular, self-expanding valve design as the CoreValve/Evolut platform. It has gold markers built into he frame to provide implanters with direct visualization of depth and valve leaflet orientation during implant. Evolut FX uses a redesigned catheter for a smoother insertion profile and more flexible delivery system for a stable, predictable deployment, according to Medtronic.

“With the latest Evolut FX system, we are elevating the p…

EU orders Illumina to divest Grail after ‘unlawful’ merger

The European Commission today announced it has ordered Illumina (Nasdaq: ILMN) — the DNA sequencing and array-based tech developer — to unwind and divest its Grail acquisition.

The decision follows the commission’s decision to prohibit the transaction in September 2022 over concerns the merger would be anticompetitive and “stifle” innovation in the market.

Despite the disapproval of the EU Commission, Illumina and Grail “unlawfully completed the merger during the commission’s in-depth investigation,” the EU said in a news release. The move was against EU merger control rules, and the commission issued significant fines to Illumina and Grail in July as a result of the proposed merger.

“Today’s decision restores competition in the development of early cancer detection tests. These tests could represent a breakthrough in our fight against cancer. By ordering Illumina to restore Grail’s independence, we ensure a leve…

Ypsomed: closed-loop insulin dosing improves health of pregnant women with type 1 diabetes

A study showed that the mylife Loop system improves the health of pregnant women with type 1 diabetes. [image courtesy of Ypsomed]Ypsomed today announced clinical study data demonstrating the benefits of its hybrid closed-loop insulin delivery system for pregnant women.

Pregnant women with type 1 diabetes and their babies benefitted from the automated insulin delivery system based on the CamDiab CamAPS FX algorithm. The New England Journal of Medicine published these outcomes from Ypsomed’s AiDAPT clinical study.

Ypsomed says the CamAPS FX is the only automated insulin delivery (AID) algorithm approved for pregnant women with type 1 diabetes. The mylife Loop system combines that algorithm with the Ypsomed YpsoPump and the Abbott FreeStyle Libre 3 or Dexcom G6 CGM.

Together, they form an intelligent and automated insulin delivery (AID) system for people with type 1 diabetes. Users can better control glucose levels and alleviate the burden of daily diab…

Fast Five: Boston Scientific wins expanded indication for SCS system, Medtech Innovator announces 2023 Grand Prize winner

Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, October 12, 2023.

Fast Five by MassDevice · Boston Scientific’s SCS system nabs new FDA approval, Medtech Innovator names Grand Prize winner

Novo Nordisk has announced that it acquired all shares of drug delivery device maker Biocorp. Fast Five host Danielle Kirsh and guest cohost Jim Hammerand discuss the deal, including when the acquisition talks began.

Ambu named its new chief financial officer for 2024. Find out who is taking over and what some of their career history is that supports this appointment.

The FDA has approved a next-gen intrathecal drug delivery system from Medtronic. Kirsh and Hammerand talk about the technology and what sets it apart from previous iterations of the device.

Medtech Innovator announced the 2023 Grand Prize winner at Ad…

Judge grants preliminary approval to Philips class action settlement

[Image from Pixabay]A federal judge in Pennsylvania has granted preliminary approval to an economic loss settlement involving lawsuits filed against Philips over its massive recall of CPAPs and other respiratory devices.

U.S. District Court Judge Joy Flowers Conti’s order, filed yesterday, could just be the beginning of settling what has arguably been one of the medical device industry’s most serious recalls in recent decades. (Here is a full timeline of the Philips recall.)

According to plaintiffs’ co-lead counsel, Philips has agreed to provide at least $479 million in compensation to device users who paid out of pocket to buy or rent the recalled devices, as well as payers who reimbursed users for the devices. Awards could range between $55.63 and $1,552.25 for each recalled device, plus a $100 award apiece for those who returned devices.

“We are pleased that Judge Conti granted preliminary approval of the Philips economic loss settlement and encou…

Getinge makes infection prevention play with Healthmark buy

Getinge announced today that it has acquired Healthmark Industries, a Fraser, Michigan–based provider of instrument care and infection control consumables.

The Swedish medtech company paid $320 million in cash for 100% of Healthmark.

The acquisition aims to bolster Getinge’s footprint in the U.S. sterile reprocessing market while paving the way for Healthmark’s global expansion. The field is more important than ever: In the U.S. alone, there are more than 2.8 million antimicrobial-resistant infections and 35,000 resulting deaths annually, according to the CDC.

“Together, we will offer a broad range of solutions to sterile processing departments in hospitals,” Stéphane Le Roy, president Surgical Workflows at Getinge, said in a news release.

“Healthmark’s position in the field of consumables for cleaning verification and packaging will be an ideal complement to our consumables, reprocessing capital equipment, and software solutions…

How can medtech companies innovate their business models?

From left: Veronica Acurio, Gio Di Napoli, Brian Montgomery and Simran Sabharwal talked business model innovation at AdvaMed’s The MedTech Conference.

In an ever-changing medtech space, how do companies keep up with the pace of change? How do companies adjust and innovate their business models to reflect that?

Leaders from some of medtech’s biggest names attempted to answer some questions around that at AdvaMed’s The MedTech Conference yesterday. (Want to find out more? Leaders from major medical device companies will discuss innovation in surgical robotics, diabetes tech, cardiovascular and neurovascular tech, oncology and more at DeviceTalks West, Oct. 18–19 in Santa Clara. Register here.)

A panel on “Disruptive Business Models in Medtech: The Next Frontier of Value-Centric Innovation” included:

Veronica Acurio, president of the Medical Solutions division, 3M; Gio Di Napoli, president of the GI operating unit at Medtronic; B…

MedTech Innovator announces 2023 Grand Prize winner

StrokeDx accepts its MedTech Innovator 2023 grand prize. [Image courtesy of Helen Shik/MedTech Innovator]MedTech Innovator, a global medtech accelerator, today announced that StrokeDx won the grand prize in its 2023 Global Competition.

StrokeDx develops a rapid, portable and affordable stroke diagnostic device. The Pasadena, California-based company won a live audience vote at AdvaMed’s The MedTech Conference on Oct. 10. It beat out four other finalists within the 2023 MedTech Innovator cohort.

Phiex, which will participate in a panel at DeviceTalks West in Santa Clara, California, Oct. 18-19, won the grand prize last year. (Learn about that panel and more at West.DeviceTalks.com).

(And want to find out more about all 10 finalist in the competition? Our DeviceTalks Weekly podcast has you covered with interviews with each of the 10 startup CEOs.)

The winner StrokeDx seeks to speed up stroke diagnosis in the critical window

The primary objective …

Boston Scientific wins expanded indication for SCS system

The WaveWriter Alpha spinal cord stimulator systems [Image courtesy of Boston Scientific]The FDA has greenlit an expanded indication for the WaveWriter Alpha spinal cord stimulator systems from Boston Scientific (NYSE: BSX) + .

The approval now includes the treatment of painful diabetic peripheral neuropathy, a diabetes complication affecting the lower extremities.

Diabetic neuropathy, a form of nerve damage often found in the legs and feet, is caused by prolonged high blood sugar levels. This condition is prevalent, with nearly half of the 37.3 million Americans with diabetes potentially experiencing it in their lifetime, according to the American Diabetes Association. Current pain management solutions are limited, with most being pain-relieving medications.

The WaveWriter Alpha SCS systems provide a non-opioid alternative, targeting chronic intractable pain in the lower extremities resulting from DPN. By sending m…

Ambu names new chief financial officer

Ambu today announced it appointed Henrik Skak Bender as chief financial officer, effective January 1, 2024.

Bender will replace Thomas Frederik Schmidt, who intends to step down on December 31. Under Schmidt’s leadership, the company said in a news release it returned to positive free cash flow and it has taken the first steps toward strong profitable growth. Ambu plans to focus on accelerating growth and improving profitability with Bender’s appointment.

“In the progression of Ambu’s Zoom In strategy, I have, together with the Board, decided to bring in a new leadership profile to execute on the next phase of Ambu’s transformation and growth journey. I am convinced that Henrik is the right profile for the CFO role at Ambu, as he brings strategic and operational experience from global companies, as well as the medical device industry. On behalf of myself and the Board, I want to thank Thomas for his contributions to Ambu, and I wish him the be…