LumiraDx issued an urgent device recall regarding a software update for its SARS-CoV-2 antigen test. The company received a customer complaint regarding a suspected false-positive result with the antigen test on Dec. 29, 2020. An investigation into the complaint identified a manufacturing issue that resulted in a small number of sequential test strips in certain […]
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Makower named new director of Stanford Byers Biodesign
The Stanford Byers Center for Biodesign last night announced a new director with a familiar face – its co-founder Josh Makower, one of the more successful and prolific medtech entrepreneurs. This represents a homecoming of sorts for Makower, who co-founded the Stanford University center with Paul Yock in 2000. For years he’s also led the […]
NIAID expresses concern over AstraZeneca’s COVID-19 vaccine data
The National Institute of Allergy and Infectious Diseases (NIAID) has announced concerns with data from AstraZeneca’s COVID-19 vaccine trial. NIAID, a wing of the National Institutes of Health (NIH), said in a statement today that it was concerned that information the company released from its AZD1222 vaccine clinical trial may be outdated. In turn, that […]
Investors sue Decision Diagnostics over COVID-19 test
Decision Diagnostics is facing legal action after the company allegedly misled investors about developing a COVID-19 diagnostic. Licgo Partners, Sovereign Partners and Paradigm Capital, all investor companies, sued Decision Diagnostics and CEO Keith Berman in federal court under allegations that Berman had falsely stated that the company was developing an at-home COVID-19 test that was […]
Allergan must face breast implant class action
A federal judge in New Jersey has shut down part of a multi-district lawsuit against Allergan over its Biocell textured breast implants but kept most other parts of the litigation. Judge Brian Martinotti ruled on March 19 that some of the plaintiffs’ claims against Allergan (now part of AbbVie) were preempted by federal law while […]
AstraZeneca touts COVID-19 vaccine study results, will seek FDA nod
AstraZeneca announced today that its COVID-19 vaccine demonstrated statistically significant efficacy in preventing COVID-19 in a U.S. trial. AZD1222, developed in a collaboration between London-based AstraZeneca and Oxford University, was 79% effective in preventing symptomatic COVID-19 and 100% effective in preventing severe disease and hospitalization, according to a news release. Efficacy was consistent across ethnicity […]
Insulet touts results from Omnipod 5 study, expects launch this year
Insulet (NSDQ:PODD) touted positive results from the first pivotal trial for its Omnipod 5 automated insulin delivery system. Omnipod 5 is the world’s first tubeless, wearable system designed to continuously adapt insulin delivery based on glucose levels and trends, according to a news release. Acton, Mass.–based Insulet said the device, which has FDA breakthrough device […]
FDA authorizes first machine learning-based screening device for COVID-19 biomarkers
The FDA announced that it authorized the first machine learning-based screening device for identifying COVID-19 biomarkers. Tiger Tech Solutions’ COVID Plus Monitor received emergency use authorization (EUA) as a non-diagnostic screening device to identify certain biomarkers that indicate some types of conditions, including hypercoagulation (which causes blood to clot more easily than normal), according to […]
Medtronic wins CE mark approval for DBS directional lead system
Medtronic (NYSE: MDT) today announced that it received CE mark approval for its SenSight directional lead system for deep brain stimulation therapy. SenSight works seamlessly with certain Medtronic neurostimulators including the Percept PC neurostimulator. It enhances the detection of local field potentials and has directional stimulation for individualized and patient-specific data with additional programming features to […]
MedTech 100 roundup: Small dip keeps industry down
The last month brought a bit of a skid for the medtech industry and after a slight rebound last week, the downward trend has returned. A strong start to 2021 came to an end in late February and carried over into March, with MassDevice‘s MedTech 100 index hitting its lowest point on March 8 (102.16). It […]
J&J leader McEvoy lays out future for medtech giant; Stryker’s Murray talks 3Dprinting
In this week’s DeviceTalks Weekly podcast — the 50th of the series— J&J’s medical device chief Ashley McEvoy makes her debut. McEvoy, EVP and chair of Medical Devices at Johnson & Johnson, delivered insights on several areas of interest including: COVID-19’s impact on J&J in the past, and what changes may remain in the future; […]