Medical Design and Outsourcing Archives - Page 114 of 154

Former Medtronic and Zimmer-Biomet VP joins back pain startup as CEO

Jeff Cambra, CEO of SpinaFX [Photo courtesy of SpinaFX]

Jeff Cambra is the new CEO of SpinaFX Medical, the back pain therapy startup said on Friday.

Cambra was previously a vice president at Zimmer Biomet (NYSE:ZBH), “leading product management for their $5 billion global reconstruction business,” SpinaFX said in a news release. He served in that role from November 2020 to June 2021, according to his LinkedIn page.

He ended a nearly 11-year career at Medtronic (NYSE:MDT) in 2020, ultimately serving as vice president and general manager of interventional therapies. SpinaFX said he “led a successful turnaround of their $400 million vertebral augmentation and oncology business through new technology innovation, strategic partnerships, acquisitions and expanding margins.”

“With my passion for the interventional space, I constantly assess and monitor multiple promising technologies, I recognized the br…

How a future-minded medtech engineer finds inspiration, innovation and creativity

Marie Ottum, principal R&D engineer in TE Connectivity’s Advanced Technology Group [Photo courtesy of Marie Ottum]

The future of medtech is the focus of TE Connectivity’s Advanced Technology Group, a team of experienced engineers tasked with identifying trends and developing new technology for devices and challenges that might not yet even exist.

Marie Ottum, principal R&D engineer in TE Connectivity’s Advanced Technology Group and global leader of the TE women’s networking group, is an expert on single-use endoscopes who was recently featured on MassDevice’s Device Talks Tuesday.

Medical Design & Outsourcing caught up with Ottum to learn more about how and where she finds inspiration, innovation and creativity. (The following has been edited for space and clarity.)

TE Connectivity single-use bronchoscope [Photo courtesy of TE Con…

Celgene scientist testifies to dismantled partnerships with Theranos due to poor test quality

Former Theranos CEO Elizabeth Holmes leaves after a hearing at a federal court in San Jose, Calif., on July 17, 2019. [Image courtesy of Reuters/Stephen Lam]

A former Celgene scientist took the stand on Wednesday in the Elizabeth Holmes federal fraud trial to testify to a partnership the company had with Theranos on certain projects.

Victoria Sung testified about speaking to Theranos in 2009 about helping the biopharmaceutical company in a drug trial for a medication that was in development to treat anemia. She said that the small, compact size of the Theranos devices were appealing to her, the Wall Street Journal reports.

Sung alleged that Celgene vetted the Theranos technology against “gold-standard” blood testing partners and did not have confidence in the results. She testified that the results provided by Theranos didn’t match to a degree that Celgene would have preferred and were “out of range,” Th…

Alva Health stroke monitor wins MedTech Innovator startup prize

Alva Health’s stroke monitor [Photo courtesy of Alva Health]

MedTech Innovator has awarded its $350,000 global startup competition grand prize to Alva Health.

Alva Health has developed a wearable, real-time stroke monitor. The New Haven, Connecticut-based startup won the medical device accelerator competition after a Wednesday vote by attendees of The MedTech Conference, organized by AdvaMed.

“Alva Health’s mission is to develop, commercialize and make accessible a first-in-class medical device that accurately detects strokes using patient-worn wearables,” Alva Health co-founder and CEO Sandra Saldana said in a news release. “This award represents a recognition of the tremendous clinical unmet need for patients, and an important milestone in Alva Health’s journey. We are grateful to the MedTech Innovator community for their support and for the opportunity to receive mentorship fro…

Schott Minifab has a deal to buy Applied Microarrays Inc.

[Photo courtesy of Schott Minifab]

Schott subsidiary Schott Minifab on Tuesday said it has negotiated the purchase of Applied Microarrays Inc. (AMI)

Australia-based Schott Minifab, which develops and manufactures microfluidic devices for point-of-care and life sciences consumables, has worked with AMI to develop biotech substrates for diagnostics applications.

The deal, expected to close in early October, expands Schott Minifab’s biosensor printing capabilities as demand grows for point-of-care microarray consumables for applications such as infectious disease testing. Tempe, Arizona-based AMI will soon move to a larger facility in the Phoenix area.

“We pride ourselves on being an end-to-end partner for the global diagnostics industry,” said Greg Wolters, head of Schott Minifab, in a news release. “Our expansive offering allows us to provide an integrated single-source collection of value-intensiv…

Henry Schein promotes top lawyers

Henry Schein (Nasdaq: HSIC) has promoted four members of its legal team to high-ranking positions.

Walter Siegel [Photo courtesy of Henry Schein]

The medical device manufacturer and distributor on Monday named SVP Walter Siegel as chief legal officer, Kelly Murphy as SVP and general counsel, Jennifer Ferrero as deputy secretary and Reid Arstark to senior counsel, mergers & acquisitions.

“Walter quickly distinguished himself throughout the Company with his integrity, legal acumen, strategic thinking, and leadership skills,” Henry Schein CEO and Board Chair Stanley Bergman said in a news release. “Walter’s new role reflects the increasing global complexity of the laws, rules, and regulations that multi-national companies must navigate. We are pleased to have Walter in this expanded role.”

Kelly Murphy [Photo courtesy of Henry Schein]

Sieg…

Former Theranos lab director faces cross-examination, says he was source for Wall Street Journal uncoverings

Theranos founder Elizabeth Holmes (center) arrives at federal court in San Jose, California on Aug. 31, 2021.[Photo by David Paul Morris/Bloomberg via Getty Images]

Former Theranos lab director Adam Rosendorff took the stand for a second day at the Elizabeth Holmes federal fraud trial to face cross-examination from the defense.

The lab director testified that he felt pressured by management to defend lab tests despite the inaccuracies, multiple media sources report. For example, in several email exchanges with Holmes’ brother Christian Holmes, Rosendorff was asked to come up with “constructive” ways of dealing with a doctor who was questioning the results of a cholesterol test performed by one of Theranos’ machines.

Rosendorff said that he told Christian Holmes that, “if you are asking me to defend these values, then the answer is no,” NBC Bay Area reports. Rosendorff also said in the email exchange that…

BioSig Technologies picks Plexus to make its signal processing tech for arrhythmia care

BioSig Technologies today announced that it has chosen Plexus as its manufacturing partner.

Neenah, Wisconsin-based Plexus will bring to market the Pure EP system, which is the company’s signal processing technology for arrhythmia care and will develop a new product pipeline for BioSig’s NeuroClear Technologies.

“We are fundamentally proud to partner with Plexus on our mission to advance therapies through technological innovation. Their engineering and manufacturing capabilities and outstanding expertise in building complex medical devices make Plexus a foundational cornerstone to support BioSig’s growth objectives now and well into the future,” BioSig CEO Kenneth Londoner said in a news release. “The recent release of our clinical data has increased physician interest in our technology. We believe that the post-pandemic recovery in elective procedures will further drive our installation footprint, and we are confident that Plexus’ first…

CDRH’s Shuren says they’re ‘starting to turn the corner’ from COVID-19

CDRH director Dr. Jeff Shuren [Image courtesy of FDA]

Medical device industry insiders will have to wait until the new year to get a better idea of the post-pandemic priorities at the FDA’s CDRH.

That was one of the big takeaways from Dr. Jeff Shuren’s remarks at the virtual CDRH Town Hall held yesterday at AdvaMed’s The MedTech Conference, which takes place this week as a combination of virtual presentations and live presentations events in Washington, D.C. and Minneapolis.

Shuren, the director of FDA’s Center for Devices and Radiological Health, said the center is “starting to turn the corner” on catching up on submissions. Additional dollars from Congress, he said, allowed CDRH to bring on more people, leverage contractors and make changes in policy and process.

FDA is even coming out of the COVID-19 pandemic with dedicated resources to establish a supply cha…

Medtronic CFO offers supply chain update as medical device industry concerns mount

Medtronic CFO Karen Parkhill [Photo courtesy of Medtronic]

Medtronic (NYSE:MDT) was among the participants in a White House semiconductor summit last week to address the continuing global shortage of electronic chips, but CFO Karen Parkhill says the world’s largest medical device manufacturer is not in same dire straits as chip buyers in other industries.

Medtronic’s supply chain is “holding up OK, but we’re seeing pressures like everybody else,” Parkhill said Friday in an interview with Medical Design & Outsourcing.

“Semi-conductors are an issue. Resins are an issue,” she said. “I think it helps that we’re a medical device manufacturer that’s producing life-saving technology … because when push comes to shove, I think we’re more important than new cars coming off the line, for example. We haven’t necessarily pulled that card, but I do think that that could help if…

SeaSpine warns of COVID-19 hit to surgical revenue

SeaSpine Holdings (NSDQ:SPNE) is the latest medical device maker warning that the SARS-CoV-2 Delta variant wave is hurting its business.

Carlsbad, California–based SeaSpine filed an update for investors with the Securities and Exchange Commission on Friday, citing “ongoing uncertainty regarding the duration and severity of COVID-19 and/or staffing shortages on spine surgery procedure volumes throughout the United States.”

Get the full story at our sister site, MassDevice.

Women may have more adverse events with left atrial appendage occlusion devices than men

Left atrial appendage occlusion (LAAO) devices on the market include Abbott’s Amplatzer Amulet (left) and Boston Scientific’s Watchman (right). [Images courtesy of Abbott and Boston Scientific]

Women appear more likely than men to experience adverse events or lengthened hospital stays from left atrial appendage occlusion (LAAO) devices, the FDA announced today.

The FDA in its letter to health care providers said that researchers have yet to determine the reason for the difference — and that it is working with device makers to determine the cause.

For now, FDA officials still think that the benefits outweigh the risks when it comes to using LAAO devices such as Abbott’s Amplatzer Amulet and Boston Scientific’s Watchman and Watchman FLX to prevent people with atrial fibrillation from experiencing strokes.

The FDA advised health providers to continue monitoring people with LAA…