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Home » Newsletters » BioWorld MedTech

BioWorld MedTech

Oct. 3, 2022

View Archived Issues
FDA website and logo

Final FDA user fee bill omits LDT regulation, accelerated drug approval program reforms

The U.S. Congress has finally managed to pass legislation that reauthorizes several FDA user fee programs, but the final vote came on the last day of the federal fiscal year and addressed a stripped-down version of previous user fee bills. While several key considerations survived the shift to a lean bill, the FDA will have to wait for another day to be authorized to regulate lab-developed tests and to revise the accelerated approval program for pharmaceuticals, measures that may be revisited before the end of the current calendar year. Read More
smart lens - Purdue University

At AAO meeting, companies focus on the newest innovations

The American Academy of Ophthalmology (AAO) annual meeting in Chicago Sept. 30 to Oct. 3 covered the waterfront in the ophthalmic market, with positive signs for continued or improving health as supply kinks work out. Hurricane Ian’s impact on the other side of the country was also a topic, as Florida accounts for a disproportionate percentage of cataract surgeries, which may be delayed as a result of the destruction in the state. We provide some highlights from the conference, analysts’ meetings with company executives and some timely new developments in the sector. Read More
Flower with dollar sign

Cranius raises $19.4M for device to treat chronic brain disease

Recent years have seen progress in treating brain disease, but one major challenge remains: getting therapeutic treatments across the blood-brain barrier. Now, Cranius LLC has raised $19.4 million to advance a device designed to bypass the blood-brain barrier and deliver medicines directly and continuously to the brain. Read More
Svante Pääbo with skull

From ancient DNA, a Nobel Prize, and perhaps modern drug targets

The Nobel Prize in Physiology or Medicine 2022 was awarded to Svante Pääbo today "for his discoveries concerning the genomes of extinct hominins and human evolution." Pääbo, who is currently the director of the Max Planck Institute for Evolutionary Anthropology in Leipzig, Germany, and his colleagues overcame extreme technical challenges to sequence the DNA of ancient hominids – because after tens of thousands of years, there is no such thing as aging well for DNA. Read More
WTO logo

Industry pushes back as WTO considers broader COVID-19 waiver

Three months after agreeing to an intellectual property waiver for COVID-19 vaccines, World Trade Organization (WTO) members are discussing expanding it to therapies, diagnostics and devices used in preventing, diagnosing and treating COVID-19 infections. Read More

GAO says public resources may be needed to provide better quality data for AI

The most conspicuous part of the data problem for artificial intelligence (AI) medical software is the bias problem, but the U.S. Government Accountability Office (GAO) says there are policy solutions despite the data ownership/monetization problem. Read More

Med-tech gainers and losers for Sept. 26-30, 2022

The top 10 med-tech stock gainers and losers for the week. Read More

Appointments and advancements for Oct. 3, 2022

New hires and promotions in the med-tech industry, including: Oncohost, Optibrium, Pharus Diagnostics, Trinity Biotech, Venus Concepts. Read More

In the clinic for Oct. 3, 2022

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Biocardia. Read More

Financings for Oct. 3, 2022

Med-tech firms raising money in public or private financings, including: Acurable. Read More

Other news to note for Oct. 3, 2022

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 3M, Artidis, Channel Medsystems, Gigcapital5, Nevro, Opgen, Qt Imaging, Selic. Read More

Regulatory actions for Oct. 3, 2022

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: GC Aesthetics, Olive Diagnostics. Read More

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