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MD+DI Author Honored with Scholarship Name
A new scholarship at Texas A&M University honors a longtime champion of its biomedical engineering program. The Dr. William Hyman Scholarship in Biomedical Engineering was announced at a tribute dinner organized by former students. Lead gifts came from three of Hyman’s...
How to Be More Like Denmark
The New York Times has a story on Denmark's digital sophistication in terms of medical treatment. The country began adopting electronic health records and other technology a decade ago. Today, most primary care physicians and nearly half of the hospitals use electronic records. The...
New Materials Web Site Aims to Help Device Firms
Materials testing, analysis, and consultancy firm CERAM (Stoke-on-Trent, Staffordshire, UK) has boosted its Web offerings to customers in the medical device industry with the launch of a revitalized Web site that provides expanded industry-specific services and a large resource of...
BioCeramic Company Aces Award Season
BioCeramic Therapeutics, a biomaterials company, and its principal founder and chief scientific officer, Molly Stevens of Imperial College London, have won the prestigious ACES Academic Enterprise Award (in the Life Sciences category), in Paris, France. The award, sponsored by...
Medical Device Ads Earn Clios
Several medical device firms won Clios (advertising awards) in the inaugural year for healthcare ads. GE earned two silver Clios with television spots for medical equipment. In one, a doctors uses a travel-sized electrocardiogram in a rural India. In the other, a man falls (...
EN 60601-1:2006 Edition 2 Update
Mike Schmidt, a medical device consultant that serves as secretary of IEC Subcommittee 62D, Cochair of the AAMI Electrical Safety Committee, sent MD&DI an announcement regarding harmonization of the EN 60601-1: 2006 standard along with the many collateral and particular...
FDA Issues HPV Test Guidance
FDA has published a draft guidance titled Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses. It contains recommendations for studies to establish the analytical and clinical...
LDTs Still Face Pressure from FDA
There is no timeline yet for doing it, but FDA still intends to regulate laboratory-developed tests (LDTs) under FDA “enforcement discretion,” CDRH acting director of chemistry and toxicology devices Courtney Harper told the RAPS annual meeting audience in September. LDTs are...
FDA Asked to Reconsider Dental Amalgam Rule
While FDA’s new leadership touts the importance of exemplary science at the agency, a 47-page petition seeking the reconsideration of the agency’s August 4 final rule on mercury-containing dental amalgam trashes the science FDA used in it. The petition also alleges a selective...
Can FDA's New Plan Better Communicate Risk to Patients?
FDA has issued a Strategic Plan for Risk Communication, outlining the agency’s efforts to release more meaningful public health information. The plan lays out a framework for FDA to provide information about products to healthcare professionals, patients, and consumers. It also...