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Regulatory actions for June 8, 2023

June 8, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avita Medical, Corneat Vision, Femasys, FX Solutions.
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Tracey Duffy speaking at podium

Consumer and industry engagement guide Australia’s device reforms

June 8, 2023
By Tamra Sami
Recent regulatory reforms to Australia’s medical device framework have shown Australia’s Therapeutic Goods Administration (TGA) a new way of collaborating with industry to make improvements and ensure patient safety, said Tracey Duffy, deputy secretary for the TGA’s Medical Devices and Product Quality Division, during the recent Ausmedtech conference in Adelaide.
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Avita Recell device

FDA approval gives Avita’s Recell room for healthy growth

June 8, 2023
By Annette Boyle
The U.S. FDA granted premarket approval to Avita Medical Inc.’s Recell system for a wide range of full-thickness skin defects, potentially quintupling the company’s market opportunity. Recell is a cell harvesting device that produces and delivers a regenerative cell suspension using a small sample of the patient’s own skin. The Spray-On Skin cells, previously approved for use in severe burns, stimulate healing and repigmentation. “This is a landmark approval representing an inflection point for Avita Medical,” said Avita CEO Jim Corbett. “The FDA approval now offers surgeons a best-in-class treatment option for a multitude of severe wounds within inpatient and outpatient settings.”
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Regulatory actions for June 8, 2023

June 8, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Capricor, Dtx, Itabmed, Janssen, Legend, Med-Life, Merz, Onquality.
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Regulatory actions for June 7, 2023

June 7, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Teleflex.
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FDA warning letters hint that med-tech compliance programs drifted during COVID

June 7, 2023
By Mark McCarty
The U.S.FDA posted two warning letters to medical device manufacturers June 6, one each to Irhythm Technologies Inc., and Steiner Biotechnology LLC, and both warnings include citations for marketing for claims that are not in the FDA-reviewed product labels.
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Map of Europe, France filled in with French flag

Committee set up in France to assess diagnostic, prognostic and predictive technology

June 7, 2023
By Bernard Banga
The French national authority for health (HAS) has provisionally set up CEDiag, a committee for assessing diagnostic, prognostic or predictive health technologies. This new national committee will cover the field of clinical procedures, including radiology, clinical biology and anatomo-cytopathology examinations, diagnostic drugs such as contrast agents used in medical imaging and radiopharmaceutical drugs, as well as medical devices such as self-testing kits.
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Smartphone displaying Stethophone app

Sparrow’s smartphone stethoscope gets FDA nod

June 7, 2023
By Meg Bryant
The U.S. FDA has given the greenlight to Sparrow Acoustics Inc. (dba Sparrow Bioacoustics) for its Stethophone, a software-based technology that allows doctors and nurses to check a patient’s heart and lung sounds using a smartphone. Providers simply hold the smartphone against the patient’s chest to listen for possible abnormalities.
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Regulatory actions for June 7, 2023

June 7, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amphera, Brainstorm, Fennec, GSK, Merck & Co., Quralis, Tscan, Vyluma.
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ASCO 2023: Accelerated approvals are both hero and obstacle

June 7, 2023
By Lee Landenberger
Since accelerated approvals first began to be granted in 1992, their pace for cancer indications has increased dramatically but a revolution in science has made it tough for the U.S. FDA to find its balance.
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