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Approvals

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Global Approvals Snapshot September 2019

September’s approvals include the US FDA’s approval of Axonics sacral neuromodulator for fecal incontinence and AMO’s Star S4 IR excimer laser for photorefractive keratectomy.

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Latest From Approvals

Hong Kong Tests Acceptance Of South Korean Device Approvals

A new trial in Hong Kong applies to class II, III and IV medical devices that are already approved by South Korea’s Ministry of Food and Drug Safety.

Approvals Hong Kong

New Guidewire 510(k) Guidance From FDA Advises On Coating Tests

Newly finalized guidance from the US agency updates its recommendations for 510(k) submissions for guidewires intended for use in coronary vasculature, peripheral vasculature and neurovasculature. The document, which replaces a 1995 guidance, reflects serious risks posed by certain guidewire coatings.

Review Pathway Guidance Documents

US FDA Issues Labeling Guidelines For Chemically Coated Devices

After discovering a correlation between certain chemically coated devices and serious adverse events, the agency has issued a couple of final guidance documents, including a labeling guidance to increase public awareness of the risks. The coating is meant to help physicians more easily slide devices – such as catheters and guidewires – into patients, but in some cases they’ve been associated with obstruction of blood vessels, stroke and death.

Regulation Approvals

QUOTED. 27 September 2019. Jay Shah.

Abbott Laboratories gained FDA approval for its low-dose, recharge-free Proclaim XR neurostimulator. See what pain specialist Jay Shah, CEO and executive medical director of the SamWell Institute for Pain Management said about it here.

Quoted Approvals

Industry Optimistic About Second CDS Draft Guidance; FDA Releases More Final Software Guidances

After strong pushback to a clinical decision support (CDS) software draft guidance, it seems the US agency has decided to heed industry concerns to take a more risk-based approach by issuing another draft of the guidance. Industry sources are applauding the FDA's move, saying it gives them another opportunity to fine-tune the regulations, which could mean fewer CDS manufacturers would be regulated by the agency.

Regulation Approvals

Abbott Wins FDA Approval For 'Low Dose' Non-Rechargeable Spinal Cord Stimulator

Abbott won US FDA approval for its Proclaim XR spinal cord stimulator. The device offers lower-dose and recharge-free neurostimulation for patients with chronic pain with a battery life for up to 10 years.

Neurology Approvals

QUOTED. 24 September 2019. Shacey Petrovic.

Diabetes company Insulet received US Food and Drug Administration clearance to market its Omnipod DASH alternate controller-enabled infusion pump as an integrated insulin pump. See what Insulet president and CEO Shacey Petrovic said about it here.

Quoted Diabetic Care

Insulet Wins FDA Clearance For Omnipod ACE Pump

Diabetes company Insulet received US FDA clearance to market its Omnipod DASH alternate controller-enabled infusion pump as an integrated insulin pump.

Diabetic Care Approvals

It’s Raining Guidance Docs: FDA Expands Abbreviated 510(k) Program

In a new final guidance, the US agency has expanded its abbreviated 510(k) program for certain devices to look beyond conformity assessments and instead look at performance criteria. Alongside the guidance, the agency also released four draft guidances for devices it is considering clearing under the new pathway.

FDA Guidance Documents
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