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DOJ charges former Stimwave CEO with fraud scheme that added a fake receiver to neurostim device

Laura Perryman, former CEO of neurostimulation device maker Stimwave, was arrested in Florida on Thursday after being accused of running a yearslong scheme to defraud …

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After slimming down, Applied Molecular Transport no closer to taking UC drug into phase 3

Applied Molecular Transport has already sacrificed a lot last year to keep its chronic pouchitis treatment on track—including 40% of its staff and early-stage pipeline …

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FDA’s first ‘safer technologies’ nod goes to Endolumik’s glowing tube to guide weight-loss surgeries

The FDA’s nascent Safer Technologies Program, or STeP, is getting a major glow-up. Half a decade after first proposing the program—which aims to speed up …

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A ‘magic whistle’: Hands-free version of COPD breath tech improves airflow, study finds

A common treatment for the breathlessness experienced by many people with chronic obstructive pulmonary disease (COPD) relies on the use of a positive-expiratory pressure (PEP) …

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FDA clears Galaxy robotic surgery system, sending lung cancer diagnosis to a new frontier

A surgical robot system developed by Noah Medical and newly cleared by the FDA is out of this world—or, at least, the current world of …

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CZI in Chi: Chan Zuckerberg Initiative sets first location for $1B biohub expansion

Just over a year after lining up another $3.4 billion to keep developing new tools and technologies toward its long-standing goal of honing our knowledge …

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Veru’s EUA ambitions crash after FDA declines to authorize its COVID treatment

When Veru swiftly wrapped up a phase 3 trial of its COVID treatment last April, expectations bubbled that the company may be able to pry …

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Viz.ai secures Bristol Myers Squibb’s backing for hypertrophic cardiomyopathy-spotting AI

Viz.ai is already an old hand at putting its disease-spotting artificial intelligence algorithms through the FDA review process, having secured the agency’s sign-off for seven …

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Olympus mounts $370M bid to acquire GI stent maker Taewoong Medical

At the end of 2019, Olympus outlined an updated game plan for its medical device business, directing its focus toward gastrointestinal, urological and respiratory care, …

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3D-printed hearts made from real patient data could pump up accuracy of TAVR implants

There are no treatments for aortic stenosis, a heart valve problem afflicting as many as a fifth of people over 65. The only solution is …

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Insulet Omnipod’s ‘higher-than-expected demand’ helps set new revenue record

Insulet broke new ground in 2021 as its annual revenues surged past the $1 billion mark for the first time—even without a splashy new product …

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Medtronic pads the case for MiniMed closed-loop system with one-year data, study of automated meal-detection app

Nearly two years after submitting its MiniMed 780G insulin delivery system to the FDA for clearance, Medtronic is still awaiting the agency’s nod—though not for …

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Destiny seals C. diff therapy’s phase 3 fate with Sebela

Destiny Pharma could be in line for $570 million thanks to a new co-development agreement with U.S.-based Sebela Pharmaceuticals for a Clostridium difficile treatment. The …

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Moderna checks a few boxes in phase 3 mRNA flu shot trial, but misses on B strains and safety

Moderna had high hopes for its first seasonal flu vaccine to enter the clinic, but, so far, the mRNA shot hasn’t quite lived up to the …

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Pfizer pulls 50% of people from phase 3 Lyme disease study for GCP violations at US trial sites

Pfizer and Valneva’s phase 3 Lyme disease vaccine clinical trial has gone badly wrong. After discovering good clinical practice (GCP) violations at some trial sites, …

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Scientists use drug to lengthen limb bones of mice with rare bone disorder, potentially avoiding surgery

Robinow syndrome disorders are very rare, but their consequences can be profound. Babies born with the genetic condition often have a cleft palate and develop …

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BD issues cybersecurity alert for hacking risk found in Alaris infusion pump software

A vulnerability found in software used to monitor some of BD’s infusion pumps could potentially give hackers access to personal data stored in the system. …

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Medtronic fined $106M in trial over TAVR device patent infringement

Medtronic was found guilty this week of infringing a patent concerning transcatheter aortic valve replacement (TAVR) systems that was awarded to Colibri Heart Valve in …

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Valproic acid, an old seizure drug, sees new potential in preserving donor hearts

Surgeons have about four hours from the moment a heart is removed from the donor to transplanting the heart into a patient. After that, the …

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NuVasive, Globus Medical ink $3.1B orthopedic device merger, sending investors scrambling

Two long-standing makers of implants and surgical tools for orthopedic procedures are set to combine into a single musculoskeletal device powerhouse. NuVasive and Globus Medical …

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