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Humanitarian Device Exemption (HDE)

FDA grants humanitarian use device status to fetal micro-pacemaker

March 27, 2015 By Brad Perriello Leave a Comment

FDA grants exemption for fetal micro-pacemaker

Comparative sizes of fetal
and adult pacemakers.
Click image to enlarge.

Researchers at Children’s Hospital Los Angeles and the University of Southern California said the FDA granted humanitarian use device status to the fetal micro-pacemaker they designed.

Filed Under: Food & Drug Administration (FDA), News Well, Pediatrics, Regulatory/Compliance Tagged With: Cardiac Rhythm Management, Children's Hospital Los Angeles, Humanitarian Device Exemption (HDE), University of Southern California

FDA approves Abiomed’s Impella RP

January 27, 2015 By Brad Perriello Leave a Comment

FDA approves Abiomed's Impella RP

Abiomed (NSDQ:ABMD) today said the FDA approved a humanitarian device exemption for its Impella RP heart pump, calling the device the 1st FDA-approved percutaneous, single-access pump for supporting the heart’s right ventricle.

Filed Under: Food & Drug Administration (FDA), News Well, Structural Heart Tagged With: Abiomed, Humanitarian Device Exemption (HDE)

Medtronic wins HDE for Enterra II neurostim device

January 23, 2015 By Brad Perriello Leave a Comment

Medtronic wins HDE for Enterra II neurostim device

Medtronic (NYSE:MDT) today said it won a humanitarian device exemption for its Enterra II device, a neurostimulation implant designed to treat the stomach disorder gastroparesis.

Filed Under: Food & Drug Administration (FDA), Neuromodulation/Neurostimulation, News Well, Regulatory/Compliance Tagged With: Gastrointestinal, Humanitarian Device Exemption (HDE)

Hypertension: CVRx wins FDA nod for Barostim neo legacy

December 17, 2014 By Val Kennedy

Hypertension: CVRx wins FDA nod for Barostim neo legacy

CVRx said yesterday that it won a humanitarian device exemption from the FDA for its Barostim neo legacy device, to treat drug-resistant hypertension.

Filed Under: Food & Drug Administration (FDA), Neuromodulation/Neurostimulation, News Well, Regulatory/Compliance Tagged With: CVRx Inc., Humanitarian Device Exemption (HDE), Hypertension

XVIVO Perfusion wins FDA approval for donor lung transport system

August 13, 2014 By Arezu Sarvestani Leave a Comment

XVIVO Perfusion wins FDA approval for donor lung transport system

The FDA granted Humanitarian Use Device approval for Sweden-based XVIVO Perfusion for its XPS tissue transport system for preserving donor lungs.

Filed Under: News Well, Pre-Market Approval (PMA) Tagged With: Humanitarian Device Exemption (HDE), Organ Transplant, XVIVO Perfusion

Press Release: FDA approves donor lung preservation device that may result in more lung transplants

August 13, 2014 By MassDevice Leave a Comment

Press Release: FDA approves donor lung preservation device that may result in more lung transplants

Filed Under: News Well, Pre-Market Approval (PMA) Tagged With: Humanitarian Device Exemption (HDE), Organ Transplant, Press Release, XVIVO Perfusion

FDA updates medtech fast-track review for rare treatments | MassDevice.com On Call

March 24, 2014 By Arezu Sarvestani Leave a Comment

MassDevice.com On Call

MASSDEVICE ON CALL — U.S. healthcare regulators released new documents in efforts to clarify the FDA’s Humanitarian Device Exemption pathway, a less-stringent review process for medical devices that treat rare diseases.

The FDA issued a new draft guidance that would allow devices to bypass some of the required safety and efficacy hurdles if it is intended to treat a population of less than 4,000 patients.

Filed Under: Food & Drug Administration (FDA), News Well, Regulatory/Compliance Tagged With: Humanitarian Device Exemption (HDE)

FDA sets a date to review XVIVO’s lung perfusion system

February 14, 2014 By Arezu Sarvestani Leave a Comment

FDA sets a date to review XVIVO's perfusion system

Sweden-based XVIVO Perfusion landed a date with the FDA to review Humanitarian Device Exemption for its XVIVO Perfusion System for preserving donor lungs.

XVIVO will meet on March 20 with the FDA’s Gastroenterology & Urology Devices Panel to review data on the device, which provides continuous perfusion of otherwise unacceptable lung tissue, allowing clinicians to reevaluate the organs for transplantation.

Filed Under: Food & Drug Administration (FDA), News Well, Regulatory/Compliance Tagged With: Humanitarian Device Exemption (HDE), Organ Transplant, XVIVO Perfusion

Invivo starts first human trial for spinal cord scaffold

April 5, 2013 By Sony Salzman Leave a Comment

invivo logo

InVivo Therapeutics (OTC:NVIV) said the FDA has given the company the green light to begin the first human clinical studies of its bioploymer scaffold, which treats traumatic spinal cord injury.

The Cambridge, Mass.-based company said it is gearing up for safety studies in 5 patients over 15 months, and is shooting for Institutional Review Board (IRB) approval at Massachusetts General Hospital.

Filed Under: News Well Tagged With: Humanitarian Device Exemption (HDE), Investigational Device Exemption (IDE), InVivo Therapeutics

InVivo Therapeutics’ spinal cord scaffold wins FDA nod

April 4, 2013 By Brad Perriello Leave a Comment

InVivo Therapeutics

InVivo Therapeutics (OTC:NVIV) said the FDA deemed its biopolymer scaffold, designed to treat spinal cord injuries, to be a humanitarian use device.

The designation means the InVivo scaffold can seek expedited approval from the FDA for a pivotal trial of the device. HUD-based exemptions cover devices aimed at treating rare diseases and health problems, so-called "orphan" conditions.

Filed Under: News Well, Regenerative Medicine, Spine Tagged With: Humanitarian Device Exemption (HDE), InVivo Therapeutics

Syncardia nabs 2 Humanitarian Use Device wins for its smaller artificial heart

March 18, 2013 By Sony Salzman Leave a Comment

SynCardia Systems won 2 new Humanitarian Use Device designations for its 50cc Total Artificial Heart as a cardiac bridge transplant device.

The new HUD designations apply to use with children, smaller women and other people with small stature. The Tuscon, Ariz.-based device manufacturer designed this device as a smaller version of its 70cc temporary Total Artificial Heart, approved in 2004, according to a press release.

Filed Under: Food & Drug Administration (FDA), News Well, Structural Heart Tagged With: Humanitarian Device Exemption (HDE), SynCardia

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