AF Ablation Procedures Driving CRM Market Expansion
Cardiac rhythm management device sales in the US are projected to grow at a compound annual rate of 2.9%, increasing to an estimated $8.2 billion in the year 2019. Two of the fastest growing sectors of the market, electrophysiology and ablation devices, will be driven by a 10% to 20% growth in the number of patients treated for atrial fibrillation.
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This week, Establishment Labs Holdings announced the FDA gave it premarket approval for Motiva breast implant, Cologuard lands FDA approval for Cologuard Plus and GE HealthCare gets FDA nod for a new imaging agent. The FDA announces another expansion for TAP into ophthalmology and radiology. The AAMI and CTA will join forces to develop standards for AI and ML-enabled health care products.
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This week, a Delaware court awarded Auris Health shareholders $1bn in a lawsuit against Johnson & Johnson; Abbott recalled some FreeStyle Libre 3 sensors; and McKesson purchased a controlling interest in a Florida cancer care chain.
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This week, a medical group sued the FDA to block a lab-developed test rule; the FDA published guidance on device classifications; Defibtec issued a recall of its chest compression device and ICU Medical updated instructions for its infusion pump batteries; Maui Imaging raised a $4m DOD grant to put imaging tech into military-based trauma units.
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Getinge says it plans to pay about $477m for organ transport and services company Paragonix Technologies in an effort to “redefine the market standard in transplantation.”
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Inari Medical is updating use instructions for a clot-removing catheter due to the potential for serious adverse effects, including death.
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The Acton, MA-based tubeless insulin pump specialist expands its indication for the Omnipod 5 AID system beyond type 1 diabetes as FDA authorization for type 2 comes sooner than Wall Street expected. Analysts expect clearances of rival systems from Tandem Diabetes Care and Medtronic in 2025, but believe Insulet is well-positioned to compete.
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This week, a medical group sued the FDA to block a lab-developed test rule; the FDA published guidance on device classifications; Defibtec issued a recall of its chest compression device and ICU Medical updated instructions for its infusion pump batteries; Maui Imaging raised a $4m DOD grant to put imaging tech into military-based trauma units.
