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
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
9/24/2015
/ 510(k) RTA ,
Diagnostic Tests ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Medical Devices ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patents ,
Personalized Medicine ,
Premarket Approval Applications ,
Proposed Regulation ,
Regulatory Oversight ,
USPTO
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
8/28/2015
/ Diagnostic Tests ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Medical Devices ,
Patients ,
Personalized Medicine ,
Pharmaceutical Industry ,
Prescription Drugs ,
Reimbursements
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
On September 30th, 2014 the U.S. Food and Drug Administration published the draft guidance entitled ”Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” (“Guidance”). The publication of the draft Guidance...more
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
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
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
On November 14, 2013, the Food and Drug Administration (“FDA”) issued a draft guidance document - “Draft Guidance for Industry, Tool Developers, and Food and Drug Administrative Staff” (“Draft Guidance”) reporting a voluntary...more
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