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Latest From Ferdous Al-Faruque
Glooko says it has found more success by pitching its diabetes management app to self-insured employers and to payers as a tool they can implement to reduce spending, rather than by pursuing reimbursement in the traditional way. It's one model for the digital-health sector in the current health-care environment.
In another blow from the US government, securities regulators have severely penalized Theranos and its cofounder, Elizabeth Holmes, for allegedly lying to investors to raise funds.
On this week's podcast, we discuss US medtech policy developments from the Centers for Medicare and Medicaid Services, the Federal Trade Commission, FDA and the Supreme Court.
The inter partes review process, which provides a non-court strategy for invalidating patents, could conceivably come to an end depending on the Supreme Court's ruling in a case this spring. Device firms have been wary of the IPR process, which can weaken patent protections, but attorneys point out that it has also been a helpful tool in fighting against the growing threat of patent trolls in medtech. While bets are for upholding the system, legal experts say device companies could fall back to other processes previously used to stop patent trolls.
Point-by-point clinical trial recommendations from US FDA's Neurological Devices Advisory Panel at a recent meeting on intracranial aneurysm devices.
23andMe gained FDA go-ahead for the first direct-to-consumer genetic test for cancer risk, as the firm continues to map out regulatory frameworks for the DTC gene-screening space with its third de novo authorization in three years.