Cue, Google's COVID-19 test provider, raises $200M in IPO

The Latest

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  GE Healthcare to buy BK Medical for $1.45B

  The deal is aimed at expansion beyond diagnostics into surgical and therapeutic interventions, with high-single-digit return on invested capital anticipated by year five, CEO Kieran Murphy said.

  M&A

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  Sponsored by IQVIA

  Curating data assets for real-time insights

  With the increasing movement toward digitalization, the competitive landscape is beginning to change.

  Research

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  FDA categorizes Cordis catheter recall linked to 8 injuries as Class I event

  The recall comes a decade after Cordis flagged up the potential for marker bands to dislodge into the vascular system when the catheter is stretched.

  Medical Devices

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  Medtronic-Axonics neuromod IP fight sees another split patent board ruling

  The dispute will drag on in the courts after PTAB's final ruling. Medtronic said it will ask a California court to lift its stay. 

  UPDATED: Sept. 23, 2021 at 9:19 a.m.

  Medical Devices

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  EU threatens Illumina for closing $8B Grail deal while still under review

  The European Commission's warning of fines and other measures is another step in a saga that could run for years. If the bloc ultimately opposes the acquisition, the path forward will be through the courts.

  Policy & Regulation

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  Paige's AI-based software gets FDA nod to help doctors identify prostate cancer

  It's the latest in a series of milestones for the startup, which has picked up 510(k) clearance for its image viewer, raised more than $220 million and partnered with Philips and Quest Diagnostics in recent years.

  Policy & Regulation

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  Boston Scientific to spend $269M for remaining stake of Devoro in latest deal

  The medtech giant's 2021 M&A spree continues, following deals of $925 million for Preventice Solutions, $1.07 billion for Lumenis' surgical business and $295 million for cardiac ablation device maker Farapulse.

  Medical Devices

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  Medtronic embolization device hit with another Class I recall, 2 deaths cited

  The action expands a 2020 recall of the brain aneurysm treatment and comes five months after the agency approved an updated version of the technology.

  UPDATED: Sept. 22, 2021 at 8:55 a.m.

  Medical Devices

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  Abbott gets FDA nod, faces uphill climb taking on Edwards, Medtronic in TAVR market

  The challenge for Abbott as the newcomer is to take share in a relatively mature market dominated by well-set incumbents, without evidence of superiority.

  Medical Devices

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  UK seeks overhaul of AI, software as a medical device regs

  The Medicines and Healthcare products Regulatory Agency is slightly ahead of the FDA, which plans to publish draft guidance for AI and SaMD this year.  

  Medical Devices

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  FDA warns of false positive risk of Abbott COVID-19 lab tests

  CEO Robert Ford called rollout of the analyzer connected to the tests as a growth driver for the diagnostics business in July.

  Diagnostics

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  Thermo Fisher COVID-19 testing forecast tops estimates, crushes 2022 guidance

  The estimated $750 million in sales versus $365 million predicted by analysts comes amid the surge of the delta variant.

  Diagnostics

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  FDA policy in response to COVID-19 offers blueprint for regulation of LDTs: study

  The agency's response to the pandemic showed it can oversee lab-developed tests, according to Massachusetts General Hospital researchers. They contend that their study could inform legislation aimed at regulating such diagnostics.

  Policy & Regulation

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  FTC warns app makers fall under breach notification rule

  The agency noted that developers of health apps and connected devices are considered healthcare providers. Any unauthorized access, including sharing information without consent, would trigger the Health Breach Notification Rule.

  Medical Devices

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  Philip Morris takes control of Vectura amid pushback against acquisition

  The tobacco giant has secured investor buy-in despite continued opposition from clinicians and reports that employees of inhaled medicine specialist Vectura are concerned about the change in ownership.

  Medical Devices

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  Q&A

  Hillrom VP of connected care talks Baxter's $10.5B buy, digital health

  The deal, medtech's largest of 2021, is driven by Hillrom's digital health presence. Trey Lauderdale, Hillrom vice president and general manager of care communications, says the Baxter acquisition is validation of their strategy.

  Medical Devices

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  FDA creates new office to drive forward digital transformation strategy

  Vid Desai, who will help lead the new Office of Digital Transformation, was also named as the agency's chief information officer. FDA is seeking an extra $75.9 million in the 2022 budget to support the modernization plan.

  Policy & Regulation

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  Hong Kong-based Prenetics to go public in US as part of $1.25B SPAC merger

  Prenetics, which is set to pocket $459 million through the deal, will use the money to step up its attack on markets targeted by companies including 23andMe, Exact Sciences and Invitae.

  M&A

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  Zimmer latest medtech to warn of delta wave drag in Q3

  The company cautioned that delta variant pressures could extend into the fourth quarter. Despite the warning of the impact on the business, Zimmer's stock price was up nearly 5% Tuesday.

  Medical Devices

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  Deep Dive

  Medtechs are boosting DTC investment, but industry still years behind pharma

  Companies are spending hundreds of millions of dollars every year on direct-to-consumer advertising as the industry focuses on marketing more to patients.

  Medical Devices

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  Delta patients clog hospitals, spur more procedure delays

  Intermountain is the latest system to announce it's postponing elective procedures starting Wednesday at 13 of its hospitals, and expects the pause to last several weeks, CEO Marc Harrison said Friday.

  Medical Devices

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  CMS moves to scrap MCIT rule due to clinical evidence concerns

  AdvaMed said the repeal of the Medicare Coverage of Innovative Technology rule is the wrong decision for patients. Analysts wrote the breakthrough device pathway could be resurrected in Cures 2.0 legislation. 

  Medical Devices

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  NuVasive warns of delta hit in Q3 as hospitals once again limit electives

  The company's update offers another early indicator that medtechs will likely be hit in the third quarter due to delta variant surges.

  Medical Devices

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  Jefferies lowers medtech outlooks as hospitals project delta pressure into Q4

  The investment bank lowered its third quarter outlook for medical device companies with revenues heavily based on surgical volumes, including Boston Scientific, Medtronic and Stryker.

  Medical Devices

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  iRhythm announces new CEO, the second since December, amid tumultuous 2021

  Quentin Blackford, who is leaving the position of chief operating officer for Dexcom, will officially take over the role on Oct. 4. iRhythm's stock price shot up by over 34% Monday morning following the announcement.

  Medical Devices

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  MedTech Europe calls for urgent clarification of EU artificial intelligence proposal

  The trade group worries "unnecessary overlaps" between the proposed AI Act and medical device regulations, such as MDR and IVDR, could affect access to products as well as lead to legal uncertainty.

  Medical Devices

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