On December 21, 2023, more than three years after the amendments to the Patent Law in 2020 (2020 Patent Law), the Implementation Regulations of the Patent Law (Rules) and the Guidelines for Patent Examination (Guidelines)...more
Amgen Inc. et al. v. Sanofi et al., No. 22-157 (U.S. 2023) -
The U.S. Supreme Court, in a unanimous decision, has affirmed the Federal Circuit’s decision invalidating Amgen’s patent claims covering a genus of antibodies...more
Life Beyond FDA Clearance or Approval: The Reimbursement Challenge -
To medical device manufacturers, winning premarket approval or 510(k) clearance from the U.S. Food and Drug Administration (FDA) is only half the battle....more
1/11/2018
/ Corporate Financing ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Health Insurance ,
Initial Public Offering (IPO) ,
Life Sciences ,
Medical Devices ,
Medicare ,
Pharmaceutical Industry ,
Popular ,
Reimbursements ,
Venture Capital
Digital health—the convergence of healthcare, devices, genomics (in some instances), and digital technology—is a fast-growing sector teeming with the promise to improve the health of millions of people. A key feature of...more
12/22/2017
/ Apple Watch ,
Centers for Medicare & Medicaid Services (CMS) ,
Digital Health ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medical Devices ,
Medicare ,
Mobile Apps ,
Telemedicine
Recently, the U.S. Food and Drug Administration (FDA) issued final guidance on deciding when to submit a new 510(k) premarket notification application for a change to an existing medical device. The guidance is far reaching...more