World of DTC Marketing

APRIL 7, 2021

I have to laugh when I hear that a pharma company is patient-centric because that’s become a slogan to make employees feel good about themselves while the costs of prescription drugs increase every year. drug spending by 9 percent” What about taxpayers? Highest-paid CEOs in 2019: Who made the list from healthcare.

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JULY 21, 2023

UroMems , a global company developing innovative, mechatronics technology to treat stress urinary incontinence (SUI), announced today that it has successfully completed the first-ever implant of the UroActive smart, automated artificial urinary sphincter (AUS) in a female patient. Food and Drug Administration).

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OCTOBER 10, 2023

Intelivation Technologies, an innovative medical device company with a cutting-edge orthopedic portfolio announced today that it has received clearance from the Food and Drug Administration for its Hammerdesis Interphalangeal Fusion System. This is a truly disruptive technology in a crowded area.

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OCTOBER 24, 2023

Food and Drug Administration (FDA) for its novel coronary artery bifurcation stenting technology. “Our unique stenting technology is designed to simplify procedures, improve patient outcomes, and reduce angioplasty times, marking a significant advancement in coronary treatments.”

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NOVEMBER 14, 2022

Food and Drug Administration (FDA). IntraOpVSP displays patient CT and MRI as three-dimensional holograms in AR headsets, helping surgeons visualize surgical plans, anatomical targets, and cutting guides alongside or overlayed on the patient. Food and Drug Administration cleared the software for use in 2022.

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MARCH 27, 2023

Food and Drug Administration (FDA) 510(k) clearance for its FalloView device. The LCD screen on the handle of the device allows the physician to visualize internal patient anatomy in line with instrument insertion. Food and Drug Administration (FDA) 510(k) clearance for its FalloView device.

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SEPTEMBER 12, 2023

Food and Drug Administration (FDA) has approved the LimFlow System to help people with CLTI who have no other suitable endovascular or surgical treatment options and are facing major amputation. At LimFlow, our vision is to achieve great outcomes for patients suffering from CLTI.

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JUNE 9, 2023

Food and Drug Administration (FDA) has granted approval for the DETOUR System to treat patients with complex peripheral arterial disease (PAD). At present, patients with long blockages of the superficial femoral artery (SFA) have limited treatment options. million Americans are affected by PAD.

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DECEMBER 12, 2022

This most recent FDA 510(k) clearance extends the system’s previous FDA clearances and permits the activation of software functionality that connects to the patient’s bedside monitor and openly transmits treatment information to the central nursing station. ” About IRRAS. Press Release by: IRRAS.

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SEPTEMBER 27, 2022

Food and Drug Administration (FDA) 510(k) clearance for its CellFX System, expanding the indication for use to include the treatment of sebaceous hyperplasia in patients with Fitzpatrick skin types I-III. Legacy MedSearch has more than 35 years of combined experience recruiting in the medical device industry.

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OCTOBER 17, 2023

Food and Drug Administration has granted Breakthrough Device Designation for its rapid bleeding risk diagnostic test. FloBio’s test determines blood clotting status and whether a patient is on popular blood thinners called Direct Oral Anticoagulants (DOACs).

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APRIL 7, 2023

Food and Drug Administration (FDA) has granted 510(k) clearance to the Axiom PSR System for use with the company’s Kinos Axiom Total Ankle System. The Axiom PSR metal resection guides sit noticeably better on the bone and offer greater saw control compared to the historically polymer patient-specific instruments.

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JANUARY 31, 2023

Food and Drug Administration has approved the company’s fourth-generation rechargeable sacral neuromodulation system. The Axonics R20 neurostimulator utilizes the same small 5cc form factor as the Axonics R15 and is paired with the same tined lead and intuitive patient remote control. Axonics, Inc., 1 ranking in 2021.

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JANUARY 4, 2023

Food and Drug Administration (FDA) 510(k) clearance of the BiWaze ® Clear System. This new airway clearance system helps patients clear their airways as well as prevent or treat atelectasis by using Oscillating Lung Expansion (OLE) therapy. We are proud to introduce this innovative OLE therapy system.”

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MARCH 21, 2023

a privately held company focused on innovative fluorescence-guided imaging technologies for cancer surgery, today announced a New Drug Application (NDA) for its LUMISIGHT Optical Imaging Agent has been submitted to the U.S. Food and Drug Administration (FDA). Lumicell, Inc.,

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FEBRUARY 13, 2023

Food and Drug Administration (FDA) 510(k) clearance and launch of the company’s upgraded AI-powered software. These initiatives are core to our transformative approach to MR imaging, making it a reality for a growing number of patients in the fast-evolving diversity of sites of care.” Hyperfine, Inc.,

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AUGUST 8, 2022

MicroPort Navibot has received 510(K) clearance from the Food and Drug Administration (FDA) in the United States for the SkyWalker System, the company’s first robot-assisted platform for orthopedic applications. Legacy MedSearch has more than 35 years of combined experience recruiting in the medical device industry.

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NOVEMBER 28, 2022

Food and Drug Administration for commercial use in the United States. Director of Global Sales and Marketing of NeuroLogica. The BodyTom 64 brings the power of innovative imaging to patients’ bedsides safely and efficiently. For more information, please visit: www.NeuroLogica.com. Press Release by: NeuroLogica.

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SEPTEMBER 13, 2023

Food and Drug Administration (FDA) via the 510(k) pathway, with potential clearance expected during the first half of 2024. The Company’s vision is to transform external breathing assistance for over 20 million patients each year that require ventilation and oxygenation via external mechanical ventilation machinery.

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OCTOBER 19, 2023

Food and Drug Administration (FDA) 510(k) clearance for the ACES Automatic Continuous Effusion Shunt System. ACES focuses on patient-centered outcomes, potentially eliminating the need for a long hospital stay and chronic drainage at home. This is a potentially perfect solution,” said David Feller-Kopman, M.D.,

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AUGUST 23, 2023

Food and Drug Administration (FDA) Circulatory Systems Devices Panel of the Medical Devices Advisory Committee met to discuss the pre-market approval application (PMA) for the Paradise Ultrasound Renal Denervation (RDN) system, indicated to reduce blood pressure in patients with hypertension. Otsuka Medical Devices Co.,

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DECEMBER 6, 2022

With ActivSight, surgeons can access critical intraoperative visual data as augmented reality overlays, helping to increase surgical outcomes and patient safety. “As We believe ActivSight will be a game-changer in the operating room by revolutionizing surgical vision and, ultimately, improving surgical care and patient safety.

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Food and Drug Administration Safety Recruitment Medical 98

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MARCH 15, 2023

In February 2022, HeartBeam partnered with LIVMOR to build a HeartBeam-branded version of LIVMOR’s FDA-cleared Halo cloud-based software platform to connect physicians and patients. HeartBeam AIMI and HeartBeam AIMIGo have not yet been cleared by the US Food and Drug Administration (FDA) for marketing in the USA or other geographies.

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JULY 14, 2023

AlloSource ® , one of the largest allograft providers creating innovative cellular and tissue products to help surgeons heal their patients, today announced the U.S. Food and Drug Administration’s 510(K) clearance of AceConnex Pre-Sutured Fascia for hip labral reconstruction and augmentation.

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DECEMBER 1, 2022

HemoSonics, LLC , a leading medical device company delivering individualized diagnostic solutions for Patient Blood Management (PBM), announced that it has received 510(k) market clearance from the U.S. Food and Drug Administration (FDA) for the Quantra Hemostasis System with QStat Cartridge. market today.

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SEPTEMBER 26, 2023

Food and Drug Administration (FDA) has approved MRI conditional labeling for the Evoke ® System, the first and only precision, dose-control spinal cord stimulation (SCS) therapy powered by SmartLoop technology. The approval provides patients implanted with the Evoke ® System the ability to undergo 1.5

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MARCH 16, 2023

The DeltaScan Brain State Monitor provides a quick and objective measurement of acute brain failure even before symptoms appear, enabling clinicians to provide immediate treatment and help patients regain cognitive well-being. It’s clear from the evidence that minimizing the duration of acute brain failure can improve outcomes.”

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JULY 18, 2023

ReddyPort announced today that the US Food and Drug Administration (FDA) granted 510(k) premarket clearance for the ReddyPort elbow device used in non-invasive ventilation (NIV). 1 The ReddyPort elbow also enables patients and clinicians to use the ReddyPort microphone.

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AUGUST 22, 2023

Levita Magnetics, whose mission is to help more patients get access to better surgery, announced today it has received U.S. Food and Drug Administration (FDA) clearance for its MARS platform. “With this FDA clearance, we eagerly anticipate making a substantial impact across the value chain.”

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OCTOBER 3, 2023

Food and Drug Administration (FDA), for its Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100). ExThera Medical’s extracorporeal products have demonstrated life-saving capabilities in a wide range of critically ill patients suffering from sepsis, COVID-19, and other severe infections.

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JULY 10, 2023

Food and Drug Administration for the use of its FREEDOM60 ® Infusion System with Hizentra ® 50 mL prefilled syringes. “This submission is another milestone in KORU Medical’s mission to make subcutaneous therapy radically simpler and easier for patients. .

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NOVEMBER 1, 2023

Food and Drug Administration (FDA) has granted Breakthrough Device Designation for Paige Lymph Node 1 , an AI application used to detect breast cancer metastases in lymph node tissue. 3 Based on an investigational clinical study conducted by Paige involving 3 pathologists and data from 148 patients. Klimstra, M.D.,

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DECEMBER 7, 2022

Food and Drug Administration market clearance for the ArthroFree System. It eliminates the camera cables associated with patient burns and fires, and it is drop-in compatible with current OR technologies. The ten-year vision: better outcomes for one million patients—and thousands of clinicians, too.

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APRIL 27, 2023

(Innoblative), a private medical device company addressing clinical unmet needs for patients with breast cancer, announced that it received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the company’s SIRA RFA Electrosurgical Device (SIRA). The post Innoblative Receives U.S.

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NOVEMBER 2, 2023

Xēnix Medical, a surgical implant company focused on the development of novel science-based solutions for patients requiring spinal fusion surgery, today announced that it has received 510(k) clearance from the U.S. Our clients include both blue-chip companies and innovative startups within the MedTech space.

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AUGUST 21, 2023

Food and Drug Administration for its new, advanced Activit-E polyethylene for the Truliant® knee replacement system. It is the next generation of highly crosslinked polyethylene with vitamin E antioxidant that is intended to further our primary goal of providing immense benefits to our patients.”

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MARCH 7, 2023

Food and Drug Administration (FDA). 1 We are proud to offer this innovative device to orthopedic trauma patients and are confident that it will make a significant impact in the lives of those in need.” Pro-X1 will be X-Bolt’s flagship launch in the United States.

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