Latest Posts › Medical Devices

Share:

HSBC Venture Healthcare Report: 1H 2024

For a succinct analysis of 1H 2024 venture investment and exit activity in life sciences and health care, take a look at HSBC’s Venture Healthcare Report, Shake it off: HSBC Innovation Banking Analysis, 1H 2024. Lead author...more

FDA Oversight of Diagnostic Medicine – A Trap for the Unwary

Diagnostic medicine is experiencing new challenges at the USPTO and the U.S. Food and Drug Administration (FDA). Under a new FDA proposal, laboratory developed test providers, previously exempt from FDA oversight, must now...more

AmerisourceBergen Guest Post: Solutions to Overcome Reimbursement Challenges in Personalized Medicine

The continued development and refinement of personalized medicine (PM) has offered an opportunity to revolutionize medical practice and improve outcomes by providing treatments for patients with the notion that “this drug is...more

Direct-to-Consumer Genetic Test Authorized by FDA

23andMe is not a traditional diagnostics company. Rather than seeking to directly sell its services to health care professionals, 23andMe went straight to the consumer, offering genetic screening and analysis in a mail-order...more

FDA Issues Draft Guidance for Regulation of LDTs

On September 30th, 2014 the U.S. Food and Drug Administration published the draft guidance entitled ”Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” (“Guidance”). The publication of the draft Guidance...more

Considering Sex-Specific Variation for Personalized Medicine

Personalized medicine may use devices and assays that identify sex-related differences. For example, a device or an assay may determine if a cancer patient harboring a particular genetic variance will or will not respond to a...more

Regulating Point of Care Diagnostics

Personalized medicine relies on diagnostic medicine to identify the best therapy for the patient at the right time. Tests that match a therapy to the patient fall into one of two categories. In vitro diagnostic devices or...more

Recommendations for NextGen Health IT Infrastructure

Health care information technology (health IT) facilitates the delivery of personalized medicine by providing and supporting the infrastructure for patients, consumers and health care providers to communicate and distribute...more

4/21/2014  /  FCC , Healthcare , Medical Devices , ONC , Technology

FDA Issues Draft Guidance to Expedite Device Development

On November 14, 2013, the Food and Drug Administration (“FDA”) issued a draft guidance document - “Draft Guidance for Industry, Tool Developers, and Food and Drug Administrative Staff” (“Draft Guidance”) reporting a voluntary...more

FDA Issues Draft Guidance to Expedite Device Development

On November 14, 2013, the Food and Drug Administration (“FDA”) issued a draft guidance document - “Draft Guidance for Industry, Tool Developers, and Food and Drug Administrative Staff” (“Draft Guidance”) reporting a voluntary...more

10 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide