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BioWorld - Wednesday, July 6, 2022
Home » Topics » North America » U.S.

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DOJ slaps owners of PODs for violations of Anti-Kickback Statute

July 5, 2022
By Mark McCarty
No Comments
Physician-owned distributorships (PODs) were the subject of concern by medical device makers and members of Congress as long as a decade ago, and recent events would seem to justify some of those fears. The U.S. Department of Justice (DOJ) announced July 1 that two owners of a POD have agreed to pay $1 million to settle claims that they paid kickbacks to other doctors to use medical devices supplied by the POD, the very kind of violation of the Anti-Kickback Statute that undergirded some of the earlier concerns about these business arrangements.
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Supreme Court passes on another opportunity to clear up Section 101 problem

July 5, 2022
By Mark McCarty
No Comments
Patent subject matter eligibility under Section 101 of the Patent Act has proven controversial for patents in the U.S. thanks in no small part to Supreme Court jurisprudence in cases such as Alice v. CLS Bank and Mayo v. Prometheus. In the latest development, the Court has declined to hear the American Axle case, which some see as presenting an exceptionally low bar for subject matter eligibility, leaving many observers despairing of any chance of restoring a decent patent system for makers of in vitro diagnostics and other items that are among the mainstays of the medical device industry.
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Intuitive Surgical’s Ion endoluminal system and Siemens Healthiness’ Cios Spin

FDA clears Intuitive, Siemens to pair 3D imaging with robotic lung biopsies

July 5, 2022
By Meg Bryant
No Comments
Lung cancer claims more lives each year than any other cancer, making early and accurate diagnosis crucial to improving survival rates. To that end, the U.S. FDA has cleared the integration of Intuitive Surgical Inc.’s Ion endoluminal system and Siemens Healthineers AG’s Cios Spin mobile imaging cone-beam CT imaging technology to enhance robotic lung biopsies.
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Libairty vest and console

Synchrony targets US market for airway clearance system

July 5, 2022
By Catherine Longworth
No Comments
Israeli startup Synchrony Medical Ltd. is gearing up to begin a U.S. clinical trial testing an airway clearance method developed at Israel’s Sheba Medical Center. The Libairty device is designed to support chronic lung disease patients to clear mucus with a short home-based daily treatment.
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US FDA prepares for track-and-trace implementation date

July 5, 2022
By Mari Serebrov
No Comments
The U.S. FDA is hailing two revised draft guidances it released July 5 as “critical steps” toward implementing the electronic drug tracing requirements of the Drug Supply Chain Security Act.
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US jury finds pay-for-delay settlement procompetitive

July 5, 2022
By Mari Serebrov
No Comments
A U.S. federal jury breathed new life into so-called pay-for-delay settlements when it found that a 2010 agreement between Endo International plc and Impax Laboratories LLC was procompetitive as it allowed Impax to launch its generic version of Opana ER, an opioid pain drug, before key patents expired.
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Researchers in lab demonstrating technology

New monitor may help surgeons detect blood clots faster

July 1, 2022
By David Godkin
No Comments
The University of Central Florida (UCF) and Orlando Health are testing new medical technology designed to identify blood clots more quickly in surgery. The monitoring device consists of a small optical fiber that uses red blood cells to track the process of blood coagulation in patients so doctors can watch for life threatening blood clot formation.
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FDA vaccine illustration

US guidance on next-gen boosters a new era in COVID-19

July 1, 2022
By Mari Serebrov
No Comments
The U.S. FDA’s guidance to COVID-19 vaccine manufacturers, announced June 30, that they should develop modified bivalent boosters that include an omicron BA.4/5 spike protein component marks the beginning of a new era in the pandemic in which manufacturers are no longer driving the development of the vaccines.
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GE Healthcare issues class I recall for ventilators due to battery issues

July 1, 2022
By Mark McCarty
No Comments
GE Healthcare issued a class I recall for Carescape R860 ventilators that covers more than 4,000 units distributed in the U.S., which was necessitated by problems with the battery backup component. No injuries or deaths have been reported in connection with the problem.
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Femasys

With Roe overturned, Femasys’ permanent contraception has increased appeal

June 30, 2022
By Annette Boyle
No Comments
If timing is everything, Femasys Inc.’s Fembloc has everything on its side. While the company’s dual tracks addressing infertility and providing permanent contraception may appear at odds, they both serve to put greater control of reproductive decisions and treatment in the hands of women. A permanent contraceptive, Fembloc offers an alternative to surgical tubal ligation by encouraging scar tissue growth in the fallopian tubes in an office-based procedure.
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