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AdvaMed supports effort to overturn J&J pelvic mesh ruling in California

Medical device trade group AdvaMed announced today that it has filed an amicus curiae brief supporting an appeal to overturn a $344 million pelvic mesh ruling against Johnson & Johnson in California.

Lawyers for AdvaMed tell the California Court of Appeal that the San Diego Superior Court judgment violated safe harbor protections because the case involved J&J communications about pelvic mesh that were FDA-approved.

“We believe the trial court misapplied California’s Unfair Competition Law and Fair Advertising Law by failing to judge the communications from the perspective of the target audience — trained physicians who treat pelvic floor conditions — over 80 of whom confirmed that the marketing materials were not likely to mislead them,” said Pat Fogarty, AdvaMed’s SVP, deputy general counsel and director of litigation.

“The decision undermines a manufacturer’s ability to rely on FDA input when it comes to the adequacy of …

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…

FDA clears ‘major’ CT advance out of Siemens Healthineers

FDA announced today that it has cleared Siemens Healthineers’ Naeotom Alpha, describing the device as the first major computed tomography advancement in nearly a decade.

The Naeotom Alpha uses the emerging CT technology of photon-counting detectors. The sensors measure each X-ray that passes through a person’s body. Previously, CT detectors have measured the total energy contained in many X-rays at once.

“Counting” each individual X-ray photon enables more detailed 3D imagery about what is going on inside a patient.

FDA official Laurel Burk noted in an FDA news release that computed tomography is an important medical imaging tool that can aid in diagnosing disease, trauma or abnormality. CT also aids in the planning and guiding of interventional or therapeutic procedures, as well as monitoring the effectiveness of certain therapies.

“Today’s action represents the first major new technology for computed tomograph…

Former Celgene scientist says partnership with Theranos ended over 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 in development to treat anemia. She said that the small, compact size of the Theranos devices appealed 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 the degree that Celgene would have preferred and were “out of range,” The Verge rep…

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…

Celgene scientist testifies to failed 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,” The Verge reports. Sung told assis…

Moderna to build a new 462,000-square-foot facility in Massachusetts

A rendering of the Moderna Science Center planned at 325 Binney St. in Cambridge, Massachusetts. [Image of courtesy of Alexandria Real Estate Equities]Moderna (Nasdaq: MRNA) announced today that it will create a 462,000-square-foot Moderna Science Center just a half-mile drive from its present headquarters location in Cambridge, Massachusetts.

Construction has started at 325 Binney St. Moderna plans to begin a phased move-in process in 2023. Alexandria Real Estate Equities — an urban office REIT — is handling the facility’s development, operation, and construction.

Get the full story on our sister site Drug Discovery & Development.

Activ Surgical closes $45M Series B funding round

Activ Surgical today announced that it has secured $45 million in a Series B funding round.

The funding round was led by Cota Capital and included seven new investors. To date, the Boston-based company has raised a total of $77 million.

Activ Surgical is developing a hardware-agnostic platform with ActivInsights augmented reality-based software for autonomous and collaborative surgery through computer vision, artificial intelligence, machine learning, AR and robotics.

The company has earmarked the funds from the Series B round to support the commercial availability of the ActivInsights software suite including the first Insight AR-based overlay that displays tissue perfusion in real-time without the need for traditional dyes. Activ Surgical also said it would use the funds to support commercialization in the U.S. and pursue a CE mark approval to support the global launch of the products.

As part of the fundraising round, Cota Capital partner Bobby…

Moderna to build a new 462,000-square-foot facility in Massachusetts

A rendering of the Moderna Science Center planned at 325 Binney St. in Cambridge, Massachusetts. [Image of courtesy of Alexandria Real Estate Equities]

Moderna (Nasdaq: MRNA) announced today that it will create a 462,000-square-foot Moderna Science Center just a half-mile drive from its present headquarters location in Cambridge, Massachusetts.

The creator of messenger RNA (mRNA) therapeutics and vaccines saw its fortunes skyrocket during the COVID-19 pandemic. It successfully created a vaccine against the novel coronavirus that millions have used in the United States and around the world. The new space, according to Moderna, will support its next chapter of discovery as it advances its pipeline of mRNA medicines. Features will include custom spaces for R&D and an integration of scientific and non-scientific areas to maximize collaboration and promote innovation.

Construction has started at 325 Bin…

Hologic expands Omni hysteroscopy offering in Europe

Hologic (Nasdaq: HOLX) announced today that it has expanded its Omni suite of gynecological surgical offerings in Europe, Africa and western Asia.

The Omni expansion gives physicians greater flexibility and choice as they optimize diagnostic and operative hysteroscopy, according to the Marlborough, Massachusetts–based women’s health company.

“The option to ‘see and treat’ is becoming more common across Europe. There is an increasing awareness of the benefits of moving these types of procedures to the outpatient environment, and this has been further highlighted by the pandemic,” said Tanja Brycker, VP of strategic development BSH & Surgical – International at Hologic.

Brycker said in a news release that gynecologists need to have access to a broader range of products that enable them to adapt quickly to the requirements of each patient. “Hologic has consulted extensively with our customers, and the latest add…

NuVasive sees first commercial cases using its Pulse platform

Pulse involves the integration of multiple spine surgery technologies into one platform [Image courtesy of NuVasive]NuVasive (NSDQ:NUVA) today announced the first commercial cases involving its Pulse spine surgery automation platform.

Drs. Michael Kachmann and Zachary Tempel from Mayfield Brain & Spine in Ohio, and Dr. Paul Holman from Houston Methodist Hospital in Texas performed the procedures. In the case of the Ohio doctors, it was an extreme lateral interbody fusion (XLIF) that took place at TriHealth’s Good Samaritan Hospital in Cincinnati.

Pulse involves the integration of multiple technologies into one platform: radiation reduction, imaging enhancement, rod bending, navigation, intraoperative neuromonitoring and spinal alignment tools. It is also able to work alongside Siemens Healthineers’ 3D mobile C-arm, the Cios Spin.

Pulse represents San Diego–based NuVasive’s answer to the rise of digital and robotic surgery offerings in …

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.

Get the full story at our sister site, Medical Design & Outsourcing.