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physiocontrol

Stryker’s Physio-Control wins FDA PMA for Lifepak defibs

July 27, 2018 By Fink Densford

Stryker‘s (NYSE:SYK) Physio-Control business said today it won FDA premarket approval for the continued marketing and distribution of its Lifepak professional defibrillators in the US. The clearance includes its Lifepak 1000, refurbished Lifepak 20 defibrillator and monitor, Lifepak 20e defibrillator and monitor and the Lifepak 15 defibrillator and monitor, the Redmond, Wash.-based company said. “Physio-Control […]

Filed Under: Cardiovascular, Food & Drug Administration (FDA), Pre-Market Approval (PMA), Regulatory/Compliance, Structural Heart Tagged With: physiocontrol, Stryker

Physio-Control initiates select recall of Lifepak 20e defibs, monitors

February 21, 2018 By Fink Densford

Physio-Control is recalling select Lifepak 20e defibrillators and monitors over issues with power failures, according to a recall notice posted this month. The voluntary recall affects Lifepak 20e units built between September 2016 and June 2017, the company said. Physio-Control said it received reports from customers of power-related failures with the devices during initial deployment […]

Filed Under: Cardiovascular, Recalls, Structural Heart Tagged With: physiocontrol

Physio-Control recalls Cardinal Health-made pediatric AED electrodes

October 30, 2017 By Fink Densford

Physio-Control said today it launched a voluntary recall of pediatric defibrillation electrodes, made by Cardinal Health (NYSE:CAH), which are components in a number of the company’s Lifepak automated external defibrillators over issues with incorrect art that could lead to misuse. Redmond, Wash.-based Physio-Control said that artwork on the recalled defibrillation electrodes shows incorrect electrode placement for […]

Filed Under: Cardiovascular, Recalls, Structural Heart Tagged With: Cardinal Health, physiocontrol

Johnson & Johnson lands $260m Defense Dept. contract for orthopedic devices

April 28, 2017 By Brad Perriello

UPDATED May 15, 2017, with comment from J&J. The U.S. Defense Dept. yesterday awarded a Johnson & Johnson (NYSE:JNJ) unit a contract for orthopedic products worth nearly $260.5 million. The 1-year contract with Piscataway, N.J.-based Johnson & Johnson Healthcare System includes 4 1-year options; the total maximum value of the agreement covers the life of the contract including […]

Filed Under: Orthopedics, Resuscitation Tagged With: defensedepartment, Johnson and Johnson, physiocontrol

7 medtech stories we missed this week: April 21, 2017

April 21, 2017 By Danielle Kirsh

From new and renewed partnerships to FDA approvals, here are 7 medtech stories we missed this week but thought were still worth mentioning. 1. Life Spine receives FDA clearance for cervical spacer system Life Spine announced in an April 19 press release that it has received FDA 510(k) clearance for its Plateau-C Ti Cervical Spacer […]

Filed Under: 510(k), Clinical Trials, Food & Drug Administration (FDA), News Well, Pre-Market Approval (PMA), Regulatory/Compliance Tagged With: Clearflow, Condor, Getinge, Life Spine, Lifetrack Medical, Mayo Clinic, Monitored Therapeutics, Owlstone Medical, physiocontrol, Remedent

FDA labels Physio-Control’s Lifepak 1000 recall as Class I

March 8, 2017 By Fink Densford

The FDA today labeled a select recall of Physio-Control Lifepak 1000 defibrillators over electrical issues as Class I. A Class 1 indication from the federal watchdog indicates “a reasonable probability that use of these products will cause serious adverse health consequences or death,” according to the agency. The company’s Lifepak 1000 defibrillator is designed to […]

Filed Under: Food & Drug Administration (FDA), Recalls Tagged With: physiocontrol

Battery issue prompts recall for Physio-Control’s LifePak 1000 AED

January 17, 2017 By Sarah Faulkner

Physio-Control said last week that it is launching a voluntary field action for its LifePak 1000 defibrillator, after reports that the device can shut down unexpectedly during treatment. The Redmond, Washington-based company has received 34 reports describing instances when customers have attempted to use the LifePak device and it has shut down due to an […]

Filed Under: Cardiovascular, Product Liability, Wall Street Beat Tagged With: physiocontrol

Stryker closes $1.3B Physio-Control deal

April 5, 2016 By Brad Perriello

Stryker (NYSE:SYK) said today that it closed the $1.28 billion acquisition of automated external defibrillator maker Physio-Control from Bain Capital. Medtronic (NYSE:MDT) sold Physio-Control to Bain for $478 million in January 2012. The all-cash deal is expected to add slightly to Stryker’s adjusted earnings per share this year, the Kalamazoo, Mich.-based company said when the deal was announced in […]

Filed Under: Mergers & Acquisitions, Resuscitation, Wall Street Beat Tagged With: physiocontrol, Stryker

Physio-Control recalls AED electrodes made by by 3rd party

March 17, 2016 By Fink Densford

Physio-Control issued an urgent field safety notice recalling certain lots of its Quik-Combo adult pacing/defibrillation/ECG electrodes and its Red-Pak preconnected system due to a potential for damage to the wire insulation. The company said that it hasn’t received any complains over the issue from customers, but that the use of products with the damaged insulation […]

Filed Under: Cardiovascular, Recalls Tagged With: physiocontrol

Stryker prices $3.5B notes offering

March 4, 2016 By Brad Perriello

Stryker (NYSE:SYK) said yesterday that it priced a senior notes offering worth $3.5 billion. The 4-tranche flotation consists of $750 million in 3-year, 2.0% fixed notes due in March 2019; $750 million in 5-year 2.625% fixed notes due in March 2021; $1.0 billion in 10-year 3.5% fixed notes due in March 2026; and another $1.0 billion in 30-year 4.625% fixed notes […]

Filed Under: Funding Roundup, Hospital Care, Mergers & Acquisitions, Wall Street Beat Tagged With: physiocontrol, Resuscitation, Sage Products, Stryker

Stryker to pay $1.3B for Physio-Control

February 16, 2016 By Brad Perriello

Stryker (NYSE:SYK) said today that it agreed to pay $1.28 billion to Bain Capital for automated external defibrillator maker Physio-Control. Medtronic (NYSE:MDT) sold Physio-Control to Bain for $478 million in January 2012. The all-cash deal, slated to close at the beginning of the 2nd quarter, is expected to add slightly to Kalamazoo, Mich.-based Stryker’s adjusted earnings […]

Filed Under: Cardiovascular, Mergers & Acquisitions, Resuscitation, Wall Street Beat Tagged With: Bain Capital, Medtronic, physiocontrol, Stryker

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