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US FDA's Voluntary Medical Device Manufacturing and Product Quality Pilot Program has become so popular that both the agency and device-makers are sending their own employees to CMMI Institute to be trained as Appraisal Team Members to assist in appraisals at device firms. See what FDA's Cisco Vicenty said about it here.
The Trump administration is prioritizing reforms to improve the reimbursement process for medical devices, and it is willing to spend money to do it. That's according to Joe Grogan, the health program associate director for the White House Office of Management and Budget. See what he said about it here.
A patient advocacy group recently met with US FDA officials to ask for new safety measures, if not a total ban, around LASIK eye surgery. See what the group's coleader, Paula Cofer, said about the dangers of LASIK here.
A lawsuit over negative pressure wound-therapy devices ended in a win for plaintiff KCI Medical Services after an Ohio federal judge ordered Healthcare Essentials Inc. to pay $645m for alleged theft. See what Judge Benita Pearson wrote about the case here.
An anterior cruciate ligament (ACL) repair technology developed by MIACH Orthopedics has secured backing from investors, including the union for National Football League players, in a new round of financing. See what MIACH founder Martha Murray said about it here.
FDA Commissioner Scott Gottlieb envisions a day when only 10% of new diagnostics will have to undergo pre-market review by the US agency to reach market. See what he said about it here.
Many legal threats faced by device and diagnostics companies come from federal law and regulations, but a growing class of strict state privacy laws protecting consumer data could open the door to new risks. See what attorney Kevin Coy said about it here.
Prominent medtech inventor and entrepreneur Mir Imran is laser-focused on robotic pill technologies. Check out what Imran said about a "smart" pill being developed by Rani Therapeutics that can deliver biologics orally.
The US Centers for Disease Control and Prevention's new clinical recommendations for health-care providers treating children with concussions or mild traumatic brain injury (mTBI) advise physicians against using advanced imaging for diagnosis. See what the CDC's Deb Houry said about the guidelines here.
Creavo Medical Technologies is trying to make "magnetocardiography" a go-to tool for emergency departments in diagnosing heart disease. See what Creavo CEO Steve Parker had to say about evidence backing the technology.
Stacy Cline Amin will join US FDA as chief counsel on Sept. 17. Amin comes from the White House, where she served as special assistant and senior associate counsel to President Trump. See what Kellyanne Conway, senior counselor to the president, said about Amin here.
Boston Scientific is building out its urology portfolio with the addition of Augmenix Inc., developer of the SpaceOAR bioabsorbable hydrogel spacer for reducing the side-effects of prostate cancer radiotherapy. See what Boston Scientific MedSurg President Dave Pierce said about it here.
When it comes to medical device approvals, how much benefit/risk uncertainty is too much? US FDA makes a pass at answering that question in a new draft guidance document; see what agency head Scott Gottlieb said about it here.
Innovation keeps device-makers growing, and even for established behemoths like Johnson & Johnson, cultivating a healthy innovative pipeline is critical to ensuring that they stay on top. J&J's Mirren Mandalia explains what he looks for when scouting for new technologies.
Post-market clinical follow-up (PMCF) is a relatively new requirement for the EU medtech sector – it's detailed for the first time in the new Medical Device and IVD Regulations. See what leading EU expert and clinical data consultant Sarah Sorrel said about PMCF here.
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