Medical Device and Pharmaceutical News
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Avanos Recalls Ballard Closed Suction Systems
May result in non-sterile devices Avanos Medical, Inc. is recalling its Ballard Closed Suction Systems after identifying a failure in the sterilization process, which may result in non-sterile devices. Use of these products could lead to serious health risks,...
The FDA Orphan Drug Program
Incentives for Rare Disease Drug Development The FDA’s Orphan Drug Program was established to encourage the development of drugs for rare diseases that affect fewer than 200,000 people in the U.S. Because these diseases often lack market incentives due to small...
FDA Grants Accelerated Approval to Multiple Myeloma Treatment
For hard-to-treat multiple myeloma On July 2, 2025, the FDA granted accelerated approval to linvoseltamab-gcpt (brand name: Lynozyfic) for adults with relapsed or refractory multiple myeloma who have received at least four prior therapies, including: A proteasome...
FDA Approves Alhemo for Patients with Hemophilia A or B
For Patients with Hemophilia A or B with Inhibitors The FDA has approved Alhemo (concizumab-mtci) for routine prophylaxis to prevent or reduce bleeding episodes in patients aged 12 and older with: Hemophilia A with factor VIII inhibitors, or Hemophilia B with factor...
First-in-Class Non-Opioid Pain Reliever: Journavx
A new non-opioid pain treatment option On January 30, 2025, the FDA granted priority review for Journavx (suzetrigine) – a first-in-class, non-opioid analgesic for treating moderate to severe acute pain in adults. How It Works Journavx targets sodium channels in the...
FDA Alert: Abiomed Impella Blood Pump Controller
Abiomed Impella blood pump controllers Controller May Fail to Detect Device Abiomed has issued an urgent safety notice for its Automated Impella Controller (AIC) due to a potentially serious issue where the system may fail to detect the Impella blood pump when...
China Implements a Ban on European Medical Devices
Growing China-EU Trade Conflict The medical device industry is now the latest battleground in a growing China-EU trade conflict – with potential ripple effects across global supply chains and health procurement markets. The AP reports that in an escalating trade...
GE HealthCare Anesthesia Systems Recall Due to Ventilation Risk
GE Carestation Anesthesia Systems GE HealthCare has issued a high-priority correction for certain Carestation anesthesia systems due to a potentially life-threatening risk when used in Volume Control Ventilation (VCV) mode. Affected Devices Carestation 620, 650, 650c...
FDA Approves DATROWAY® Breast Cancer Treatment
A new breast cancer treatment option The United States Food and Drug Administration (FDA) approved DATROWAY® (datopotamab deruxtecan-dlnk) on January 17, 2025, for adults with hormone receptor-positive (HR+), HER2-negative breast cancer that is unresectable or...
A Dangerous and Unapproved Drug Sold as a “Cure”
The dangers of tianeptine FDA warns that tianeptine is sold online and even at gas stations as a supposed treatment for depression, anxiety, pain, and opioid withdrawal. But don’t be fooled — this drug is not approved by the FDA for any medical use in the U.S. and has...